NCT05180266

Brief Summary

Menopause is a natural phenomenon and physiological process in middle-aged women. It is noted that women most often complain of vasomotor symptoms and sleep disorders during the menopausal period, and therefore their quality of daily life is negatively affected. Reduce symptoms and improve quality of life for menopausal women they are applying for medical approaches due to the side effects of the method compared to music, yoga, aromatherapy, therapeutic massage, physical exercise, sleep hygiene education, therapeutic touch, acupressure, acupuncture and cognitive behavioral therapy as a non pharmacological methods, it is observed that they resort to such methods. Therefore, the aim of this study is to investigate the effect of therapeutic touch and music listening on sleep quality, menopausal symptoms and quality of life in menopausal women. Therefore, the aim of this study is to investigate the effect of therapeutic touch and music listening on sleep quality, menopausal symptoms and quality of life in menopausal women.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2022

Completed
Last Updated

January 6, 2022

Status Verified

January 1, 2022

Enrollment Period

12 months

First QC Date

November 28, 2021

Last Update Submit

January 2, 2022

Conditions

Menopause

Keywords

Menopausal SymptomsSleep QualityTherapeutic TouchMusic listening

Outcome Measures

Primary Outcomes (6)

  • The effect of therapeutic touch on sleep quality

    Pittsburgh Sleep Quality Index: The index consists of a total of 24 questions and 7 components. The sum of the scores from the seven components gives the total Pittsburgh Sleep Quality Index score. The total Pittsburgh Sleep Quality Index score can take a value between 0-21. The sleep quality of individuals with a total Pittsburgh Sleep Quality Index score of 5 or less was "good"; The sleep quality of individuals with a score above 5 points is evaluated as "poor". Pre-test data in the research will be obtained with the Menopause Symptoms Rating Scale. After completing the scale, women will receive therapeutic touch once a week for four weeks. At the end of the fourth week, the Menopause Symptoms Rating Scale will be filled again.

    eleven months

  • The effect of therapeutic touch on menopausal symptoms

    Menopause Symptoms Rating Scale : There are a total of 11 questions on the Likert-type scale, including menopausal complaints. Each question is scored from 0 to 4. While the minimum score that can be taken from the scale is 0, the maximum score is 44. The increase in the total score obtained from the scale shows the increase in the severity of the complaints, while at the same time it shows that the quality of life is negatively affected. Pre-test data in the research will be obtained with the Menopause Symptoms Rating Scale. After completing the scale, women will receive therapeutic touch once a week for four weeks. At the end of the fourth week, the Menopause Symptoms Rating Scale will be filled again.

    eleven months

  • The effect of therapeutic touch on quality of life

    Menopause-Specific Quality of Life Scale: The validity and reliability of the scale was determined by Kharbouch and Şahin in 2007 by adapting the scale to Turkish society Menopause-Specific Quality of Life Scale is a 29-item Likert-type scale. Each question score is ranked from 0 to 6. A score of 0 indicates that women do not have any problems with that subject. A score of 1 indicates that there is a problem with that subject, it is experienced, but it is not disturbing at all. Scores between 2 and 6 indicate the severity and increasing degrees of the existing problem. An increase in the scale score indicates an increase in the severity of the complaints. Pre-test data in the research will be obtained with the Menopause Specific Quality of Life Scale. After completing the scale, women will receive therapeutic touch once a week for four weeks. At the end of the fourth week, the Menopause-Specific quality of life scale will be filled again.

    eleven months

  • The effect of listening to music on sleep quality

    Pittsburgh Sleep Quality Index: The index consists of a total of 24 questions and 7 components. The sum of the scores from the seven components gives the total Pittsburgh Sleep Quality Index score. The total Pittsburgh Sleep Quality Index score can take a value between 0-21. The sleep quality of individuals with a total Pittsburgh Sleep Quality Index score of 5 or less was "good"; The sleep quality of individuals with a score above 5 points is evaluated as "poor". Pre-test data in the study will be obtained with the Pittsburgh Sleep Quality Index. After the scale is filled, relaxation music will be sent to the women's phones. He will be asked to listen to this music for 30 minutes before going to sleep for four weeks. At the end of the fourth week, the Pittsburgh Sleep Quality Index will be administered again.

    eleven months

  • The effect of listening to music on menopausal symptoms

    Menopause Symptoms Rating Scale : The Turkish validity and reliability study of the scale was carried out by Gürkan in 2005. There are a total of 11 questions on the Likert-type scale, including menopausal complaints. Each question is scored from 0 to 4. While the minimum score that can be taken from the scale is 0, the maximum score is 44. The increase in the total score obtained from the scale shows the increase in the severity of the complaints, while at the same time it shows that the quality of life is negatively affected. Pre-test data in the study will be obtained with the Menopause Symptoms Rating Scale. After the scale is filled, relaxation music will be sent to the women's phones. He will be asked to listen to this music for 30 minutes before going to sleep for four weeks. At the end of the fourth week, the Menopause Symptoms Rating Scale will be administered again.

    eleven months

  • The effect of listening to music on quality of life

    Menopause-Specific Quality of Life Scale: Menopause-Specific Quality of Life Scale is a 29-item Likert-type scale. Each question score is ranked from 0 to 6. A score of 0 indicates that women do not have any problems with that subject. A score of 1 indicates that there is a problem with that subject, it is experienced, but it is not disturbing at all. Scores between 2 and 6 indicate the severity and increasing degrees of the existing problem. An increase in the scale score indicates an increase in the severity of the complaints. Pre-test data in the study will be obtained with the Menopause-Specific Quality of Life Scale. After the scale is filled, relaxation music will be sent to the women's phones. He will be asked to listen to this music for 30 minutes before going to sleep for four weeks. At the end of the fourth week, the Menopause-Specific Quality of Life Scale will be administered again.

    eleven months

Study Arms (3)

Therapeutic Touch Group

EXPERIMENTAL

In order to examine the effects of therapeutic touch on menopausal symptoms, sleep and quality of life, women will be given therapeutic touch for 15 minutes, once a week for four weeks.Therapeutic touchis a form of descriptive treatment that lasts approximately 15-20 minutes, in which hands are used on or near the body to correct abnormalities in the person's energy field and to achieve healing, and the energy in the universe is transferred from the practitioner's hands to the applied individual.

Other: Therapeutic Touch

Music Listening Group

EXPERIMENTAL

The women were asked to listen to the relaxation music included in the relaxation exercises CD prepared by the Turkish Psychological Association every day for four weeks in a comfortable environment at home for 30 minutes before bedtime.

Other: Music Listening Group

Control Group

OTHER

No action will be taken on the control group for four weeks.

Other: Control Group

Interventions

Therapeutic TouchOTHER

Each of the women will be informed about the purpose and content of the study at the first meeting, and informed consent will be obtained from the women who meet the conditions for participation and agree to participate. The pre-test data in the research will be obtained with the Participant Identification Form, PSQI,MRS and MENQOL. After pre-test data collection, women will be given an appointment for therapeutic administration.The therapeutic touch group will be applied to the therapeutic touch group once a week for four weeks in a suitable room in the Faculty of Nursing and on the specified day and time by the researcher.At the end of the fourth week, post-test data will be obtained by filling in PSQI, MRS and MENQOL again.

Therapeutic Touch Group
Music Listening GroupOTHER

Each of the women was informed about the purpose and content of the study at the first meeting, and informed consent was obtained from the women who met the conditions for participation and accepted to participate.The pre-test data in the research will be obtained with the Participant Identification Form, PSQI, MRS and MENQOL. Music stream, music will be uploaded to mobile phones. He will be asked to listen to music (relaxation music in the relaxation exercises CD prepared by the Turkish Psychological Association) for 30 minutes before going to sleep every day for four weeks. At the end of the fourth week, post-test data will be obtained by filling in PSQI, MRS and MENQOL again

Music Listening Group
Control GroupOTHER

Each of the women will be informed about the purpose and content of the study at the first meeting, and informed consent will be obtained from the women who meet the conditions for participation and agree to participate.The pre-test data in the research will be obtained with the Participant Identification Form, PSQI, MRS and MENQOL. No action will be taken on the control group for four weeks. At the end of the fourth week, post-test data will be obtained by filling in PSQI, MRS and MENQOL again.

Control Group

Eligibility Criteria

Age45 Years - 59 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • between the ages of 45-59
  • Not taking Hormone Replacement Therapy,
  • No psychiatric history,
  • Women who do not use any other CAM methods will be included in the study.

You may not qualify if:

  • Those who are in surgical menopause,
  • Having auditory problems that prevent listening to music,
  • Using any other TAT method,
  • Women who use drugs that affect sleep (using antidepressant, antihistamine, benzodiazepan, hypnotic and narcotic drugs) will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, 44000, Turkey (Türkiye)

RECRUITING

Related Publications (32)

  • Abedian Z, Eskandari L, Abdi H, Ebrahimzadeh S. The Effect of Acupressure on Sleep Quality in Menopausal Women: A Randomized Control Trial. Iran J Med Sci. 2015 Jul;40(4):328-34.

    PMID: 26170519BACKGROUND

  • Marlatt KL, Beyl RA, Redman LM. A qualitative assessment of health behaviors and experiences during menopause: A cross-sectional, observational study. Maturitas. 2018 Oct;116:36-42. doi: 10.1016/j.maturitas.2018.07.014. Epub 2018 Jul 21.

    PMID: 30244777BACKGROUND

  • Kamalifard M, Farshbaf-Khalili A, Namadian M, Ranjbar Y, Herizchi S. Comparison of the effect of lavender and bitter orange on sleep quality in postmenopausal women: A triple-blind, randomized, controlled clinical trial. Women Health. 2018 Sep;58(8):851-865. doi: 10.1080/03630242.2017.1353575. Epub 2017 Aug 25.

    PMID: 28749734BACKGROUND

  • Adimi Naghan P, Hassani S, Sadr M, Malekmohammad M, Khoundabi B, Setareh J, Seyedmehdi SM, Seifi S. Sleep Disorders and Mental Health in Menopausal Women in Tehran. Tanaffos. 2020 Jan;19(1):31-37.

    PMID: 33101429BACKGROUND

  • Xu Q, Lang CP. Examining the relationship between subjective sleep disturbance and menopause: a systematic review and meta-analysis. Menopause. 2014 Dec;21(12):1301-18. doi: 10.1097/GME.0000000000000240.

    PMID: 24800878BACKGROUND

  • Moudi A, Dashtgard A, Salehiniya H, Sadat Katebi M, Reza Razmara M, Reza Jani M. The relationship between health-promoting lifestyle and sleep quality in postmenopausal women. Biomedicine (Taipei). 2018 Jun;8(2):11. doi: 10.1051/bmdcn/2018080211. Epub 2018 May 28.

    PMID: 29806589BACKGROUND

  • Cintron D, Lipford M, Larrea-Mantilla L, Spencer-Bonilla G, Lloyd R, Gionfriddo MR, Gunjal S, Farrell AM, Miller VM, Murad MH. Efficacy of menopausal hormone therapy on sleep quality: systematic review and meta-analysis. Endocrine. 2017 Mar;55(3):702-711. doi: 10.1007/s12020-016-1072-9. Epub 2016 Aug 11.

    PMID: 27515805BACKGROUND

  • Cao Y, Yin X, Soto-Aguilar F, Liu Y, Yin P, Wu J, Zhu B, Li W, Lao L, Xu S. Effect of acupuncture on insomnia following stroke: study protocol for a randomized controlled trial. Trials. 2016 Nov 16;17(1):546. doi: 10.1186/s13063-016-1670-0.

    PMID: 27852282BACKGROUND

  • Lima AM, Rocha JSB, Reis VMCP, Silveira MF, Caldeira AP, Freitas RF, Popoff DAV. [Loss of quality of sleep and associated factors among menopausal women]. Cien Saude Colet. 2019 Jul 22;24(7):2667-2678. doi: 10.1590/1413-81232018247.19522017. Portuguese.

    PMID: 31340284BACKGROUND

  • Attarian H, Hachul H, Guttuso T, Phillips B. Treatment of chronic insomnia disorder in menopause: evaluation of literature. Menopause. 2015 Jun;22(6):674-84. doi: 10.1097/GME.0000000000000348.

    PMID: 25349958BACKGROUND

  • Crivello, A., Barsocchi, P., Girolami, M., & Palumbo, F. (2019). The meaning of sleep quality: a survey of available technologies. IEEE access, 7, 167374-167390.

    BACKGROUND

  • Troynikov O, Watson CG, Nawaz N. Sleep environments and sleep physiology: A review. J Therm Biol. 2018 Dec;78:192-203. doi: 10.1016/j.jtherbio.2018.09.012. Epub 2018 Oct 5.

    PMID: 30509635BACKGROUND

  • Hachul, H., & Polesel, D. N. (2017). Insomnia pharmacotherapy: a review of current treatment options for insomnia in menopause. Current sleep medicine reports, 3(4), 299-305.

    BACKGROUND

  • Afonso RF, Hachul H, Kozasa EH, Oliveira Dde S, Goto V, Rodrigues D, Tufik S, Leite JR. Yoga decreases insomnia in postmenopausal women: a randomized clinical trial. Menopause. 2012 Feb;19(2):186-93. doi: 10.1097/gme.0b013e318228225f.

    PMID: 22048261BACKGROUND

  • Johnson A, Roberts L, Elkins G. Complementary and Alternative Medicine for Menopause. J Evid Based Integr Med. 2019 Jan-Dec;24:2515690X19829380. doi: 10.1177/2515690X19829380.

    PMID: 30868921BACKGROUND

  • HÖzcan, H., Çakmak, S., & Salman, E. (2020). Complementary and Alternative Medicine Methods Used for Sleep Disturbance in Menopause. Journal of Turkish Sleep Medicine, 3, 207-213.

    BACKGROUND

  • Vardar, O., Özkan, S., & Sercekus, P. (2020). Postmenopozal kadınlarda uygulanan egzersiz programının uyku kalitesine etkisi. Cukurova Medical Journal, 45(3), 1108-1114.

    BACKGROUND

  • j. V. Dall, "Promoting sleep with therapeutic touch," Addict. Nurs. Netw., vol. 5, no. 1, pp. 23-24, 1993.

    BACKGROUND

  • Tabatabaee A, Tafreshi MZ, Rassouli M, Aledavood SA, AlaviMajd H, Farahmand SK. Effect of Therapeutic Touch in Patients with Cancer: a Literature Review. Med Arch. 2016 Apr;70(2):142-7. doi: 10.5455/medarh.2016.70.142-147. Epub 2016 Apr 1.

    PMID: 27194823BACKGROUND

  • Cordi MJ, Ackermann S, Rasch B. Effects of Relaxing Music on Healthy Sleep. Sci Rep. 2019 Jun 24;9(1):9079. doi: 10.1038/s41598-019-45608-y.

    PMID: 31235748BACKGROUND

  • Liu YH, Lee CS, Yu CH, Chen CH. Effects of music listening on stress, anxiety, and sleep quality for sleep-disturbed pregnant women. Women Health. 2016;56(3):296-311. doi: 10.1080/03630242.2015.1088116. Epub 2015 Sep 11.

    PMID: 26361642BACKGROUND

  • Dickson GT, Schubert E. How does music aid sleep? literature review. Sleep Med. 2019 Nov;63:142-150. doi: 10.1016/j.sleep.2019.05.016. Epub 2019 Jun 8.

    PMID: 31655374BACKGROUND

  • Chen CT, Tung HH, Fang CJ, Wang JL, Ko NY, Chang YJ, Chen YC. Effect of music therapy on improving sleep quality in older adults: A systematic review and meta-analysis. J Am Geriatr Soc. 2021 Jul;69(7):1925-1932. doi: 10.1111/jgs.17149. Epub 2021 Apr 20.

    PMID: 33880759BACKGROUND

  • J. Cohen, Statistical Power Analysis for the Behavioral Sciences., 2nd ed. 1988.

    BACKGROUND

  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

    PMID: 2748771BACKGROUND

  • M. Ağargün, H. Kara, and Ö. Anlar, "Pitsburg Uyku Kalitesi İndeksinin Geçerliği ve Güvenirliği.," Türk Psikiyatr. Derg., vol. 7, no. 2, 1996.

    BACKGROUND

  • Ö. C. Gürkan, "Menopoz semptomları değerlendirme ölçeğinin Türkçe formunun güvenirlik ve geçerliliği.," Hemşirelik Forumu Derg., vol. 3, pp. 30-35, 2005.

    BACKGROUND

  • Hilditch JR, Lewis J, Peter A, van Maris B, Ross A, Franssen E, Guyatt GH, Norton PG, Dunn E. A menopause-specific quality of life questionnaire: development and psychometric properties. Maturitas. 1996 Jul;24(3):161-75. doi: 10.1016/s0378-5122(96)82006-8.

    PMID: 8844630BACKGROUND

  • N. H. ŞAHİN, N. H., Kharbouch, S. B., & Şahin, "Menopozal dönemlerdeki yaşam kalitesinin belirlenmesi.," Florence Nightingale Hemşirelik Dergisi, vol. 15, no. 59, pp. 82-90, 2007.

    BACKGROUND

  • Meehan TC. Therapeutic touch as a nursing intervention. J Adv Nurs. 1998 Jul;28(1):117-25. doi: 10.1046/j.1365-2648.1998.00771.x.

    PMID: 9687138BACKGROUND

  • J. Macrae, Therapeutic Touch. izmir: Ege Meta Yayınları, 2000.

    BACKGROUND

  • Keskin Tore F, Yagmur Y. The effects of therapeutic touch and music on sleep quality, menopausal symptoms, and quality of life in menopausal women. Menopause. 2023 Dec 1;30(12):1221-1229. doi: 10.1097/GME.0000000000002269. Epub 2023 Oct 24.

    PMID: 37874963DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Therapeutic TouchControl Groups

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • FATMA KESKİN

    Inonu University

    PRINCIPAL INVESTIGATOR

  • YURDAGÜL YAĞMUR, Professor

    Inonu University

    STUDY DIRECTOR

Central Study Contacts

FATMA KESKİN, Msc

CONTACT

5448171444keskinfatma989@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: After the preliminary test is applied to the experimental groups, therapeutic touch will be applied to one group by the researcher and music listening will be applied to the other group. Once a week for four weeks after the preliminary test data Therapeutic Touch Group; Therapeutic Touch application will be performed by the researcher at the appointed time. Each therapeutic touch will take 15 minutes, in accordance with the literature information. At the end of the fourth week, the final test data will be obtained. Music Listening Group: After the preliminary test data, women will be asked to listen to relaxation music every day for four weeks for 30 minutes before bedtime in a comfortable environment at home. At the end of the fourth week, the final test data will be obtained. To the Control Group; no intervention will be made to women after the preliminary test data.At the end of the fourth week, the final test data will be obtained.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

November 28, 2021

First Posted

January 6, 2022

Study Start

September 3, 2021

Primary Completion

August 25, 2022

Study Completion

August 25, 2022

Last Updated

January 6, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)