Clinical trial NCT05298527: BACK MASSAGE APPLIED CLIMACTERIC WOMEN MENOPAUSAL COMPLAINTS, SLEEP QUALITY AND MARITAL ADJUSTMENT
Official title: THE EFFECT OF BACK MASSAGE APPLIED BY PARTNERS TO CLIMACTERIC WOMEN WITH SLEEP PROBLEM ON MENOPAUSAL COMPLAINTS, SLEEP QUALITY AND MARITAL ADJUSTMENT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Climactericum
Sleep
Keywords: climacteric period
menopausal complaint
back massage
sleep quality
marital adjustment
Lead sponsor: Nuh Naci Yazgan University
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 126
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was conducted as the randomized controlled experimental trial.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Climacterium is a life period in which women move from the reproductive age to the period when their reproductive ability is lost due to the decrease in ovarian functions. The most common climacteric disorder is vasomotor changes. The most common problem seen in menopausal period after vasomotor complaints is insomnia.

Sleep disorders seen in climacteric period negatively affect the quality of life and psychosocial health of woman. In their study, Jean-Louis et al., expressed that women in menopausal period spent approximately 10% of their daily sleep time by sleeping outside the bed during the day. 61% of menopausal women woke up at least once a week and several times from the night's sleep. In their study, Anttalainen et al., determined that women in postmenopausal period had more sleep problems compared to women in premenopausal period. In addition to physical changes due to hormonal changes in climacterium, mental problems such as nervousness, anxiety and depression developing in women may negatively affect the relationships in family environment especially the communication with the spouse. Besides, it is thought that an incompatible marriage can increase menopausal complaints. In the studies investigating the relationship between menopausal complaints and marital adjustment, women with compatible marital life were found to experience less menopausal complaints. Due to the negative effects of physician-controlled hormone replacement treatment administered to reduce menopausal symptoms, demand for non-pharmacological interventions has increased and women have started to accept that therapeutic massage is safe and contributes to health. It is stated that women experience insomnia, a symptom of menopause, and tend to choose especially body therapies from alternative therapies in the first place. Massage is widely accepted as a treatment tool. Although the menopausal period is physiological, it is a period that must be addressed specifically by healthcare professionals since it is accompanied by pathological events causing distress in life and impairing the quality of life.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 4 minutes
measure: Menopause Symptoms Rating Scale (MSRS)
timeFrame: 2 minutes
measure: Marital Adjustment Scale (MAS)
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Nuh Naci Yazgan University
state: Kocasinan/Kayseri
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.