NCT05545761

Brief Summary

About one-third of women experience no or mild symptoms during their menopausal life, while another third experience moderate symptoms, while the remaining one-third may experience severe symptoms. It is stated that hormone therapy, one of the pharmacological methods, is accepted as an effective and standard method in the management of menopausal symptoms, including sleep disorders and depression, despite its side effects. However, due to the health risks associated with hormone therapy, it is stated that many women do not want to use this treatment option and turn to complementary and alternative medicine to alleviate menopausal symptoms. It is stated that physical, mental and psychological problems of women can be treated with non-pharmacological methods such as relaxation, breathing exercises, touch therapy, and music therapy as a complementary and alternative medicine approach in the world and in Turkey. It is stated that the healing effect of music has been known among societies since ancient times. Today, with technological developments, it is stated that music does not only rest the soul, but also has a cognitively stimulating effect and a motivating effect in cases where verbal communication cannot be performed. When the national and international literature is examined, there are many studies on non-pharmacological methods for menopausal symptoms, while the effect of music therapy on depression in menopausal women was examined in only one study in Turkey. However, no study was found in which the music therapy method was used for both depression and sleep quality in menopausal women. For this reason, the aim of the study was to determine the effect of music therapy, which is a non-pharmacological method, on sleep quality and depression in menopausal women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

July 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2022

Enrollment Period

2 months

First QC Date

September 7, 2022

Last Update Submit

December 24, 2024

Conditions

Keywords

music therapydepressionsleep quality

Outcome Measures

Primary Outcomes (3)

  • Pittsburgh sleep quality index (PUKI)

    The maximum and minimum total scores that can be obtained from the Pittsburgh sleep quality index (PUKI) scale range from 0 to 21. Sleep quality will be defined as poor in women who score 5 or more on this scale.

    5 weeks after the start of music therapy

  • Beck Depression Scale

    While the maximum score to be obtained from the Beck Depression Scale is 63, it will be accepted that the presence and severity of depression increase as the score from the scale increases. The woman who gets a maximum of 10 points will be defined as no depression.

    5 weeks after the start of music therapy

  • Menopausal Symptoms Evaluation Scale

    The total score that can be obtained from the Menopausal Symptoms Evaluation Scale is between 0-44. The increase in the total score obtained from the scale indicates the increase in the severity of the complaints.

    5 weeks after the start of music therapy

Study Arms (2)

intervention group

EXPERIMENTAL

music will be played to the intervention group. They will be asked to listen to the Hüseyni makam for at least 15 minutes at 11.00 in the morning, 5 times a week for 5 weeks, and to listen to the Zirgüle makam for at least 15 minutes at 20.00 on the same day.

Other: music therapy

control group

NO INTERVENTION

group that does not listen to music and is not interfered with

Interventions

Feedback will be received via WhatsApp that the participants have listened to the maqam conveyed to them.Before applying music therapy in the experimental group, they will be asked to fill out the questionnaires.At the end of the music therapy application, the questionnaires made at the beginning will be applied to the experimental group again.No application will be made to the control group, and data collection forms will be applied twice with an interval of 4 weeks.

intervention group

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsmenopausal
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Menopausal
  • PSQI average score of 5 and above
  • No hearing problem
  • Not taking HRT at the time of the study or in the past year
  • There was no diagnosis of a psychiatric disease during the study.

You may not qualify if:

  • Having communication problems, Receiving HRT treatment during the study or in the last year, Not attending music therapy sessions,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Health Sciences Gülhane Faculty of Health Sciences

Ankara, 06018, Turkey (Türkiye)

Location

Meryem VURAL ŞAHİN

Ankara, Çankaya, Turkey (Türkiye)

Location

Related Publications (23)

  • Augoulea A, Moros M, Lykeridou A, Kaparos G, Lyberi R, Panoulis K. Psychosomatic and vasomotor symptom changes during transition to menopause. Prz Menopauzalny. 2019 Jun;18(2):110-115. doi: 10.5114/pm.2019.86835. Epub 2019 Jun 28.

    PMID: 31485208BACKGROUND
  • Trimarco V, Rozza F, Izzo R, De Leo V, Cappelli V, Riccardi C, Di Carlo C. Effects of a new combination of nutraceuticals on postmenopausal symptoms and metabolic profile: a crossover, randomized, double-blind trial. Int J Womens Health. 2016 Oct 11;8:581-587. doi: 10.2147/IJWH.S115948. eCollection 2016.

    PMID: 27785106BACKGROUND
  • Chen X, Wei Q, Jing R, Fan Y. Effects of music therapy on cancer-related fatigue, anxiety, and depression in patients with digestive tumors: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2021 Jun 4;100(22):e25681. doi: 10.1097/MD.0000000000025681.

    PMID: 34087821BACKGROUND
  • Weidner K, Bittner A, Beutel M, Goeckenjan M, Brahler E, Garthus-Niegel S. The role of stress and self-efficacy in somatic and psychological symptoms during the climacteric period - Is there a specific association? Maturitas. 2020 Jun;136:1-6. doi: 10.1016/j.maturitas.2020.03.004. Epub 2020 Mar 13.

    PMID: 32386660BACKGROUND
  • Zhang J, Shao S, Ye C, Jiang B. A Clinical Study of the Effect of Estradiol Valerate on Sleep Disorders, Negative Emotions, and Quality of Life in Perimenopausal Women. Evid Based Complement Alternat Med. 2021 Oct 16;2021:8037459. doi: 10.1155/2021/8037459. eCollection 2021.

    PMID: 34697549BACKGROUND
  • Heinemann LA, Potthoff P, Schneider HP. International versions of the Menopause Rating Scale (MRS). Health Qual Life Outcomes. 2003 Jul 30;1:28. doi: 10.1186/1477-7525-1-28.

    PMID: 12914663BACKGROUND
  • Mehrnoush V, Darsareh F, Roozbeh N, Ziraeie A. Efficacy of the Complementary and Alternative Therapies for the Management of Psychological Symptoms of Menopause: A Systematic Review of Randomized Controlled Trials. J Menopausal Med. 2021 Dec;27(3):115-131. doi: 10.6118/jmm.21022.

    PMID: 34989185BACKGROUND
  • Kocak DY, Varisoglu Y. The effect of music therapy on menopausal symptoms and depression: a randomized-controlled study. Menopause. 2022 May 1;29(5):545-552. doi: 10.1097/GME.0000000000001941.

    PMID: 35486946BACKGROUND
  • Djapardy V, Panay N. Alternative and non-hormonal treatments to symptoms of menopause. Best Pract Res Clin Obstet Gynaecol. 2022 May;81:45-60. doi: 10.1016/j.bpobgyn.2021.09.012. Epub 2021 Nov 17.

    PMID: 34952794BACKGROUND
  • Kavurmaci M, Dayapoglu N, Tan M. Effect of Music Therapy on Sleep Quality. Altern Ther Health Med. 2020 Jul;26(4):22-26.

    PMID: 31221932BACKGROUND
  • Hachul H, Monson C, Kozasa EH, Oliveira DS, Goto V, Afonso R, Llanas AC, Tufik S. Complementary and alternative therapies for treatment of insomnia in women in postmenopause. Climacteric. 2014 Dec;17(6):645-53. doi: 10.3109/13697137.2014.926321. Epub 2014 Jul 16.

    PMID: 24884736BACKGROUND
  • Lafci, D. (2018). Breast cancer, sleep and music therapy. Journal of Uludag University Faculty of Medicine, 44(1), 61-64.

    BACKGROUND
  • Hisli, N. (1988). A study on the validity of the Beck Depression Inventory. Journal of Psychology, 6(22), 118-122

    BACKGROUND
  • Metintas S, Arykan I, Kalyoncu C, Ozalp S. Menopause Rating Scale as a screening tool in rural Turkey. Rural Remote Health. 2010 Jan-Mar;10(1):1230. Epub 2010 Mar 31.

    PMID: 20356316BACKGROUND
  • BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.

    PMID: 13688369BACKGROUND
  • Gözüyenice, E., & Başer, M. (2016). Vasomotor Complaints Experienced in Menopausal Period. Anatolian Journal of Nursing and Health Sciences, 19(4).

    BACKGROUND
  • Orlowski, D. D., Can, U. K., & Bagci, H. (2021). Investigation of Scientific Publications in the Field of Music Therapy in Germany (2010-2019). Motif Academy Journal of Folklore, 14(33), 266-286.

    BACKGROUND
  • Ocebe, D. K., Kolcu, M., & Kadriye, U. Z. U. N. (2019). Music Therapy and Elderly Health. Health Sciences University Journal of Nursing, 1(2), 112-115.

    BACKGROUND
  • Velioğlu, E., & Gürkan, Ö. C. (2021). Evidence-Based Complementary and Alternative Therapies in the Management of Menopausal Symptoms. Journal of Traditional and Complementary Anatolian Medicine, 3(2), 20-27.

    BACKGROUND
  • Zhao K, Bai ZG, Bo A, Chi I. A systematic review and meta-analysis of music therapy for the older adults with depression. Int J Geriatr Psychiatry. 2016 Nov;31(11):1188-1198. doi: 10.1002/gps.4494. Epub 2016 Apr 19.

    PMID: 27094452BACKGROUND
  • Şahan, Ö., & Oskay, Ü. M. R. A. N. (2021). Sleep changes and management in the postmenopausal period. Journal of Health Academics, 8(4), 350-359.

    BACKGROUND
  • Amiri, S., Parvizi Fard, A., Khaledi-Paveh, B., Foroughi, A., Bavafa, A., Bazani, M., ... & Sadeghi, K. (2019). The effect of music therapy using Persian traditional music on insomnia. Kermanshah Medical Sciences University Journal, 23

    BACKGROUND
  • E. E. M. Elsabagh and E. S. Abd Allah, "Menopausal symptoms and the quality of life among pre/post-menopausal women from rural area in Zagazig city," Life Science Journal, vol. 9, no. 2, pp. 283-291, 2017.

    BACKGROUND

MeSH Terms

Conditions

DepressionSleep Initiation and Maintenance Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PHD Student

Study Record Dates

First Submitted

September 7, 2022

First Posted

September 19, 2022

Study Start

July 1, 2022

Primary Completion

September 1, 2022

Study Completion

November 1, 2022

Last Updated

December 27, 2024

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations