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Completed

NCT Number: NCT05298527

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

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nuh Naci Yazgan University

Kayseri, Kocasinan/Kayseri, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 4 minutes

    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.

  2. Menopause Symptoms Rating Scale (MSRS)

    Time frame: 2 minutes

    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.

  3. Marital Adjustment Scale (MAS)

    Time frame: 3 minutes

    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.

Sponsors and collaborators

Lead sponsor

Nuh Naci Yazgan University

Other

Registry information

Official study title

THE EFFECT OF BACK MASSAGE APPLIED BY PARTNERS TO CLIMACTERIC WOMEN WITH SLEEP PROBLEM ON MENOPAUSAL COMPLAINTS, SLEEP QUALITY AND MARITAL ADJUSTMENT

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Mar 28, 2022
Registry last updated
Mar 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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