ClimactericumNCT05298527
BACK MASSAGE APPLIED CLIMACTERIC WOMEN MENOPAUSAL COMPLAINTS, SLEEP QUALITY AND MARITAL ADJUSTMENT
A study testing Back Massage in people with Climactericum and Sleep, run by Nuh Naci Yazgan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Climactericum, Sleep
- What is being tested?
- Back Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2016to 1 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nuh Naci Yazgan University
Kayseri, Kocasinan/Kayseri
About this study
Official title: THE EFFECT OF BACK MASSAGE APPLIED BY PARTNERS TO CLIMACTERIC WOMEN WITH SLEEP PROBLEM ON 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.
Read the 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.
- Conditions
- Climactericum, Sleep
- Being tested
- Back Massage
- Keywords
- climacteric period, menopausal complaint, back massage, sleep quality, marital adjustment
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Back MassageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 May 2016
- Primary completion15 Jul 2016
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ClimactericumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was conducted as the randomized controlled experimental trial.
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuh Naci Yazgan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DİDEM KAYA, Nuh Naci Yazgan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298527
- Sponsor's protocol ID
- NuhNaciYazganU
- Status last verified
- Mar 2022
- First submitted
- 17 Mar 2022
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared after the article is published.
Publications
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.
PubMed 10795722Kripke 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.
PubMed 21461131Anttalainen 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.
PubMed 17091421Hachul 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.
PubMed 26483913Newton 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.
PubMed 12100799Oliveira 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.
PubMed 21484056Oliveira 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.
PubMed 22017318
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF BACK MASSAGE APPLIED BY PARTNERS TO CLIMACTERIC WOMEN WITH SLEEP PROBLEM ON MENOPAUSAL COMPLAINTS, SLEEP QUALITY AND MARITAL ADJUSTMENT
- ClinicalTrials.gov ID
- NCT05298527
- Acronym / sponsor ID
- NuhNaciYazganU
- Conditions
- Climactericum, Sleep
- Keywords
- climacteric period, menopausal complaint, back massage, sleep quality, marital adjustment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Nuh Naci Yazgan UniversityUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 15 Jul 2016 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was conducted as the randomized controlled experimental trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Back MassageIn 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. |
| 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Back MassageThe 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. | Behavioural | Intervention Group |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- Background: PubMed 10795722Jean-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.
- Background: PubMed 21461131Kripke 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.
- Background: PubMed 17091421Anttalainen 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.
- Background: PubMed 26483913Hachul 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.
- Background: PubMed 12100799Newton 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.
- Background: PubMed 21484056Oliveira 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.
- Background: PubMed 22017318Oliveira 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.
- Individual participant dataSharing planned: No. It will be shared after the article is published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Back Massage in people with Climactericum and Sleep, run by Nuh Naci Yazgan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI) (time frame: 4 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05298527, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.