BACK MASSAGE APPLIED CLIMACTERIC WOMEN MENOPAUSAL COMPLAINTS, SLEEP QUALITY AND MARITAL ADJUSTMENT

NCT05298527 | Completed DMC

• 1 other identifier: NuhNaciYazganU
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effect of back massage applied by partners on menopausal complaints, sleep quality, and marital adjustment of women in climacteric period.

Conditions

Climactericum; Sleep

Keywords

climacteric period; menopausal complaint; back massage; sleep quality; marital adjustment

Outcome Measures

Primary Outcomes (3)

• Pittsburgh Sleep Quality Index (PSQI)

  It is a scale developed by Buysse et al., in 1989. Its validity and reliability study was conducted in 1996 by Ağargün et al. PSQI provides a quantitative measure of sleep quality. There are 24 questions in the scale and 19 of these questions are self-rated. PSQI total score of 5 or higher indicates poor sleep quality. The Cronbach's alpha internal consistency coefficient of the scale, whose validity and reliability was conducted by Ağargün et al. was determined as 0.80.

  4 minutes

• Menopause Symptoms Rating Scale (MSRS)

  The Menopause Symptoms Rating Scale, originally called as Menopause Rating Scale, was developed in German by Schneider, Heinemann et al. in 1992 to determine the severity of menopausal symptoms and their effect on quality of life. The English adaptation, validity and reliability of the scale were conducted in 1996 by Schneider, Heinemann et al. The validity and reliability study of the scale was conducted in Turkey by Özlem Can Gürkan. The minimum score of the scale is "0" and the maximum score is "44". The high total score of the scale indicates that both quality of life is low and menopausal complaints are high. In the validity and reliability study by Gürkan, the Cronbach's alpha internal consistency coefficient was found as 0.84.

  2 minutes

• Marital Adjustment Scale (MAS)

  MAS, developed by Locke and Wallace in 1959, is composed of 15 items. The validity and reliability of the scale was conducted by Tutarel-Kışlak in 1999. It was found that the scale can significantly distinguish coupes with and without marital problems. The cut-off point of the scale is 43. While scores lower than 43 refer to a general marital maladjustment, scores higher than 43 indicate overall marital adjustment. In the validity and reliability study of Tutarel-Kışlak, the Cronbach's alpha internal consistency coefficient of the scale was found as 0.90.

  3 minutes

Study Arms (2)

Intervention Group

EXPERIMENTAL

In this study, the purpose of the study was explained to the women from intervention group and their partners by visiting them in their home. Personal Information Form (PIF), Pittsburgh Sleep Quality Index (PSQI), Menopause Symptoms Rating Scale (MSRS) and Marital Adjustment Scale (MAS) were filled by the women and MAS was filled by their partners. Firstly, back massage was taught to the partners of women in the intervention group. The massage was made half an hour before the women's sleep time for a total of 15 minutes. Partners were ensured to apply this massage twice a week for four weeks. The intervention group was called by telephone every week to ensure continuity of the study. By visiting those at their homes again at the end of the fourth week, PSQI, MSRS, and MAS were filled by the women and MAS was filled by their husbands for the last time.

Behavioral: Back Massage

Control Group

NO INTERVENTION

In this study, the purpose of the study was explained to the women from control group and their partners by visiting them in their home. Their signatures indicating that they agreed to participate in the study were obtained after having them read the informed consent form. Personal Information Form (PIF), Pittsburgh Sleep Quality Index (PSQI), Menopause Symptoms Rating Scale (MSRS) and Marital Adjustment Scale (MAS) were filled by the women and MAS was filled by their partners. No application was made to the couples in the control group. By visiting those at their homes again at the end of the fourth week, PSQI, MSRS, and MAS were filled by the women and MAS was filled by their husbands for the last time. Back massage training was given to the partners of the women in the control group at the end of the fourth week.

Interventions

Back Massage BEHAVIORAL

The woman lies face down and a pillow is placed under her forehead. Massage begins with effleurage. Petrissage is started from the sacrum and the hands are lifted up to the nape and repeated 4 times. After the petrissage movement is completed, effusion is applied to the area once. Friction is applied. After rubbing, tapotement is applied to the entire back.

Intervention Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women aged between 40-65 years,
• women who have 5 or more points from Pittsburgh Sleep Quality Index (PSQI),
• women who do not use hormone therapy or who stopped hormone therapy at least one year ago.

You may not qualify if:

• women who had sleep problems before climacteric period,
• women who had uncontrolled chronic disease,
• women receiving psychiatric treatment and/or using sleeping pills,
• women with open wounds on their back were excluded from the study group.

Sponsors & Collaborators

• Nuh Naci Yazgan University: lead

Study Sites (1)

Nuh Naci Yazgan University

Kayseri, Kocasinan/Kayseri, Turkey (Türkiye)

Location

Related Publications (7)

• Jean-Louis G, Kripke DF, Assmus JD, Langer RD. Sleep-wake patterns among postmenopausal women: a 24-hour unattended polysomnographic study. J Gerontol A Biol Sci Med Sci. 2000 Mar;55(3):M120-3. doi: 10.1093/gerona/55.3.m120.

  PMID: 10795722 BACKGROUND

• Kripke DF, Brunner R, Freeman R, Hendrix SL, Jackson RD, Masaki K, Carter RA. Sleep Complaints of Postmenopausal Women. Clin J Womens Health. 2001 Dec 1;1(5):244-252. doi: 10.1053/cjwh.2001.30491.

  PMID: 21461131 BACKGROUND

• Anttalainen U, Saaresranta T, Aittokallio J, Kalleinen N, Vahlberg T, Virtanen I, Polo O. Impact of menopause on the manifestation and severity of sleep-disordered breathing. Acta Obstet Gynecol Scand. 2006;85(11):1381-8. doi: 10.1080/00016340600935649.

  PMID: 17091421 BACKGROUND

• Hachul H, Oliveira DS, Bittencourt LR, Andersen ML, Tufik S. The beneficial effects of massage therapy for insomnia in postmenopausal women. Sleep Sci. 2014 Jun;7(2):114-6. doi: 10.1016/j.slsci.2014.09.005. Epub 2014 Sep 16.

  PMID: 26483913 BACKGROUND

• Newton KM, Buist DS, Keenan NL, Anderson LA, LaCroix AZ. Use of alternative therapies for menopause symptoms: results of a population-based survey. Obstet Gynecol. 2002 Jul;100(1):18-25. doi: 10.1016/s0029-7844(02)02005-7.

  PMID: 12100799 BACKGROUND

• Oliveira D, Hachul H, Tufik S, Bittencourt L. Effect of massage in postmenopausal women with insomnia: a pilot study. Clinics (Sao Paulo). 2011;66(2):343-6. doi: 10.1590/s1807-59322011000200026. No abstract available.

  PMID: 21484056 BACKGROUND

• Oliveira DS, Hachul H, Goto V, Tufik S, Bittencourt LR. Effect of therapeutic massage on insomnia and climacteric symptoms in postmenopausal women. Climacteric. 2012 Feb;15(1):21-9. doi: 10.3109/13697137.2011.587557. Epub 2011 Oct 23.

  PMID: 22017318 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Doctor

Model Details: The study was conducted as the randomized controlled experimental trial.

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 28, 2022
• Study Start: May 1, 2016
• Primary Completion: July 15, 2016
• Study Completion: January 1, 2017
• Last Updated: March 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)