Menopause SyndromeNCT05293860
Effects of Connective Tissue Manipulation on Menopausal Symptoms
A study testing Connective tissue manipulation and Superficial massage with the head of the therapeutic ultrasound device in people with Menopause Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Menopause is defined as the permanent cessation of menstruation as a result of the loss of ovarian follicular function. This process involves some bothersome physical and psychological climacteric symptoms. The most common symptoms are vasomotor symptoms, psychological symptoms and sleep disturbances. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Menopause Syndrome
- What is being tested?
- Connective tissue manipulation and Superficial massage with the head of the therapeutic ultrasound device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2022to 26 Apr 2023
- 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between the 45 and 65 years,
- Being experienced at least 3 moderate or severe hot flashes, sweating or night sweats per day for at least 3 months,
- Being in the natural/spontaneous postmenopausal (amenorrhea for at least 12 months) period for less than 10 years,
- Having stable vital signs (heart rate, blood pressure),
- Volunteer to participate in the study,
- Have signed the informed consent form.
Who cannot join
- Neurological diseases,
- Uncontrolled systemic and metabolic diseases (uncontrolled diabetes mellitus, hypertension, etc.)
- History of cancer,
- History of surgical menopause,
- Obesity (BMI > 35 kg/m²),
- Use of any hormonal or non-hormonal treatment for vasomotor or other menopausal symptoms in the past 6 months,
- Psychiatric and mental disorders that prevent the cooperation to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Menopause is defined as the permanent cessation of menstruation as a result of the loss of ovarian follicular function. This process involves some bothersome physical and psychological climacteric symptoms. The most common symptoms are vasomotor symptoms, psychological symptoms and sleep disturbances.
The aim of this study is to investigate the effects of CTM on postmenopausal symptoms, menopause-specific quality of life (MENQoL) and insomnia.
For this purpose, 58 postmenopausal women who meet the inclusion criteria and volunteer to participate in the study will be randomly assigned to one of the two research arms; CTM or sham control. The participants in the experimental group will receive CTM for 5-20 minutes, 3 times a week for 4 weeks, whereas the participant in the sham control group will receive superficial massage with the head of the therapeutic ultrasound device for 15 minutes at the same frequency for 4 weeks. In this study, primary outcome is menopausal symptom severity and will be assessed by the \"Menopause Rating Scale\". Secondary outcomes are hot flash frequency, hot flash score (frequency X severity), menopause-specific quality of life, emotional status and insomnia. These outcomes will be assessed by daily diaries and the questionnaires; \"Menopause-Specific Quality of Life Scale\", \"Depression-Anxiety-Stress 21 Scale\" and \"Insomnia Severity Index\". All outcome measurements will be evaluated at baseline and after the intervention period. Then, the results will be compared within groups and between two study groups.
Read the detailed description
Menopause is defined as the permanent cessation of menstruation as a result of the loss of ovarian follicular function. It is part of the natural aging process and occurs by declining the estrogen secretion from the ovaries. This process involves some bothersome physical and psychological climacteric symptoms that negatively influence the women\'s well-being and quality of life. The most common symptoms are vasomotor symptoms (hot flashes, sweating, night sweats), psychological symptoms (anxiety, depression, stress) and insomnia. Although hormonal and non-hormonal pharmacological methods are widely used effective approaches to control these symptoms, they have some risks or adverse side effects. For this reason, women tend to alternative therapies and complementary medicine methods to improve climacteric symptoms and their quality of life.
Connective tissue manipulation (CTM) is a manual reflex therapy method which aims to restore the balance between the sympathetic and parasympathetic components of the autonomic nervous system. It is characterised by special type of manual stroke which is applied to the connective tissue. These stretching maneuvers are applied to areas called \"reflex zones\", and create local, segmental and general therapeutic effects in the body.
The aim of this study is to investigate the effects of CTM on postmenopausal symptoms, menopause-specific quality of life (MENQoL) and insomnia.
For this purpose, 58 postmenopausal women ages between 45 to 65 who meet the inclusion criteria and volunteer to participate in the study will be randomly assigned to one of the two research arms, CTM or sham control. The women in the experimental group will receive CTM for 5-20 minutes, 3 times a week for 4 weeks. On the other hand, the women in the sham control group will receive superficial massage with the head of the therapeutic ultrasound device for 15 minutes at the same frequency for 4 weeks. In this study, primary outcome is menopausal symptom severity and it will be evaluated by \"Menopause Rating Scale\". Secondary outcomes are hot flash frequency, hot flash score (frequency X severity), menopause-specific quality of life, emotional status and insomnia. These outcomes will be assessed by daily diaries and the questionnaires \"Menopause-Specific Quality of Life Scale\", \"Depression-Anxiety-Stress 21 Scale\" and \"Insomnia Severity Index\".
The diaries will be filled out for one week (7 days each); at the baseline and just after the completion of the study. All other outcome measurements will be performed before and immediately after the study is completed. The results will be compared within groups and between two study groups.
- Conditions
- Menopause Syndrome
- Being tested
- Connective tissue manipulation, Superficial massage with the head of the therapeutic ultrasound device
- Keywords
- Menopause, Vasomotor symptom, Massage, Connective tissue massage, Connective tissue manipulation, Physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective tissue manipulationOther
Connective tissue manipulation will be applied to participants' back for 5-20 minutes, 3 times a week for 4 weeks in this group.
Superficial massage with the head of the therapeutic ultrasound deviceOther
Superficial massage with the head of the therapeutic ultrasound device will be applied to participants' back for 15 minutes, 3 times a week for 4 weeks in this group.
| Study group | Role | What they receive |
|---|---|---|
| Connective tissue manipulation | Experimental | Connective tissue manipulation will be applied to participants' back for 5-20 minutes, 3 times a week for 4 weeks in this group. Receives: Other: Connective tissue manipulation |
| Superficial massage with the head of the therapeutic ultrasound device | Sham comparator | Superficial massage with the head of the therapeutic ultrasound device will be applied to participants' back for 15 minutes, 3 times a week for 4 weeks in this group. Receives: Other: Superficial massage with the head of the therapeutic ultrasound device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of menopausal symptoms
The severity of menopausal symptoms will be evaluated with the Menopause Rating Scale (MRS). MRS was developed to assess the severity of 11 symptoms associated with menopause. Each of the 11 symptoms may score between 0 (no symptoms) and 4 points (severe symptoms), depending on the perceived severity of the complaints. The total score of the MRS ranges between 0 (asymptomatic) and 44 (highest degree of complaints).
Measured: Change in the severity of menopausal symptoms from baseline to at the end of the 4th week.
Secondary outcomes (5)
Frequency of vasomotor symptoms
Frequency of hot flashes, sweating and night sweats will be assessed by daily diaries. Participants will record their hot flashes, sweating and night sweats during seven days at the baseline and just after the completion of the study.
Measured: Change in the frequency of vasomotor symptoms from baseline to at the end of the 4th week.
Vasomotor symptom intensity
The vasomotor symptom intensity, which will be obtained by multiplying the frequency and severity (mild, moderate, severe) of hot flashes, sweating and night sweats assessed by daily diaries. Participants will record their hot flashes, sweating and night sweats during seven days at the baseline and just after the completion of the study.
Measured: Change in the vasomotor symptom score from baseline to at the end of the 4th week.
Quality of life associated with menopause
Menopause-related quality of life will be assessed with the Menopause Specific Quality of Life Questionnaire (MENQOL). MENQOL was developed to determine how changes in the physical, psychological and social areas during the menopausal period affect the quality of life of women. The scale is an eight-point Likert-type scale and consists of 29 questions.
Measured: Change in quality of life associated with menopause from baseline to at the end of the 4th week.
Level of psychological symptoms
The level of psychological symptoms will be evaluated with the Depression, Anxiety and Stress Scale-21 (DASS-21). DASS-21 is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.
Measured: Change in the level of psychological symptoms from baseline to at the end of the 4th week.
Severity of insomnia
Severity of insomnia will be evaluated with the Insomnia Severity Index (ISI). ISI is a seven-item, five-point Likert-type questionnaire to assess the severity of sleep disturbance during the past two weeks. Total scores range from 0 to 28, with higher combined scores indicating worse insomnia severity.
Measured: Change in severity of insomnia from baseline to at the end of the 4th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start15 Apr 2022
- Primary completion26 Apr 2023
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Menopause SyndromeStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Hitit University
- Responsible party
- Principal investigator, SERAP ÖZGÜL, Hacettepe University
- Investigators
- Serap Özgül, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293860
- Sponsor's protocol ID
- 499
- Status last verified
- Jun 2024
- First submitted
- 15 Mar 2022
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gracia CR, Freeman EW. Onset of the Menopause Transition: The Earliest Signs and Symptoms. Obstet Gynecol Clin North Am. 2018 Dec;45(4):585-597. doi: 10.1016/j.ogc.2018.07.002. Epub 2018 Oct 25.
PubMed 30401544Roberts H, Hickey M. Managing the menopause: An update. Maturitas. 2016 Apr;86:53-8. doi: 10.1016/j.maturitas.2016.01.007. Epub 2016 Jan 22.
PubMed 26921929Santoro N, Epperson CN, Mathews SB. Menopausal Symptoms and Their Management. Endocrinol Metab Clin North Am. 2015 Sep;44(3):497-515. doi: 10.1016/j.ecl.2015.05.001.
PubMed 26316239Cobin RH, Goodman NF; AACE Reproductive Endocrinology Scientific Committee. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY POSITION STATEMENT ON MENOPAUSE-2017 UPDATE. Endocr Pract. 2017 Jul;23(7):869-880. doi: 10.4158/EP171828.PS.
PubMed 28703650Holey LA, Dixon J. Connective tissue manipulation: a review of theory and clinical evidence. J Bodyw Mov Ther. 2014 Jan;18(1):112-8. doi: 10.1016/j.jbmt.2013.08.003. Epub 2013 Sep 8.
PubMed 24411158Fu P, Gibson CJ, Mendes WB, Schembri M, Huang AJ. Anxiety, depressive symptoms, and cardiac autonomic function in perimenopausal and postmenopausal women with hot flashes: a brief report. Menopause. 2018 Dec;25(12):1470-1475. doi: 10.1097/GME.0000000000001153.
PubMed 29916944Guttuso T Jr, DiGrazio WJ, Reddy SY. Review of hot flash diaries. Maturitas. 2012 Mar;71(3):213-6. doi: 10.1016/j.maturitas.2011.12.003. Epub 2012 Jan 9.
PubMed 22230663Schneider HP, Heinemann LA, Rosemeier HP, Potthoff P, Behre HM. The Menopause Rating Scale (MRS): reliability of scores of menopausal complaints. Climacteric. 2000 Mar;3(1):59-64. doi: 10.3109/13697130009167600.
PubMed 11910611Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
PubMed 7726811Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.
PubMed 21532953Hilditch JR, Lewis J, Peter A, van Maris B, Ross A, Franssen E, Guyatt GH, Norton PG, Dunn E. A menopause-specific quality of life questionnaire: development and psychometric properties. Maturitas. 1996 Jul;24(3):161-75. doi: 10.1016/s0378-5122(96)82006-8.
PubMed 8844630Albayrak G, Cagliyan Turk A, Ozgul S. Effects of connective tissue massage on physical and emotional symptoms, insomnia, and quality of life in postmenopausal women: A randomized, sham-controlled trial. Maturitas. 2025 Jan;191:108149. doi: 10.1016/j.maturitas.2024.108149. Epub 2024 Nov 7.
PubMed 39522476
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Connective Tissue Manipulation on Menopausal Symptoms
- ClinicalTrials.gov ID
- NCT05293860
- Acronym / sponsor ID
- 499
- Conditions
- Menopause Syndrome
- Keywords
- Menopause, Vasomotor symptom, Massage, Connective tissue massage, Connective tissue manipulation, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Hitit University
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 24 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.
Menopause is defined as the permanent cessation of menstruation as a result of the loss of ovarian follicular function. This process involves some bothersome physical and psychological climacteric symptoms. The most common symptoms are vasomotor symptoms, psychological symptoms and sleep disturbances.
The aim of this study is to investigate the effects of CTM on postmenopausal symptoms, menopause-specific quality of life (MENQoL) and insomnia.
For this purpose, 58 postmenopausal women who meet the inclusion criteria and volunteer to participate in the study will be randomly assigned to one of the two research arms; CTM or sham control. The participants in the experimental group will receive CTM for 5-20 minutes, 3 times a week for 4 weeks, whereas the participant in the sham control group will receive superficial massage with the head of the therapeutic ultrasound device for 15 minutes at the same frequency for 4 weeks. In this study, primary outcome is menopausal symptom severity and will be assessed by the \"Menopause Rating Scale\". Secondary outcomes are hot flash frequency, hot flash score (frequency X severity), menopause-specific quality of life, emotional status and insomnia. These outcomes will be assessed by daily diaries and the questionnaires; \"Menopause-Specific Quality of Life Scale\", \"Depression-Anxiety-Stress 21 Scale\" and \"Insomnia Severity Index\". All outcome measurements will be evaluated at baseline and after the intervention period. Then, the results will be compared within groups and between two study groups.
Detailed description
Menopause is defined as the permanent cessation of menstruation as a result of the loss of ovarian follicular function. It is part of the natural aging process and occurs by declining the estrogen secretion from the ovaries. This process involves some bothersome physical and psychological climacteric symptoms that negatively influence the women\'s well-being and quality of life. The most common symptoms are vasomotor symptoms (hot flashes, sweating, night sweats), psychological symptoms (anxiety, depression, stress) and insomnia. Although hormonal and non-hormonal pharmacological methods are widely used effective approaches to control these symptoms, they have some risks or adverse side effects. For this reason, women tend to alternative therapies and complementary medicine methods to improve climacteric symptoms and their quality of life.
Connective tissue manipulation (CTM) is a manual reflex therapy method which aims to restore the balance between the sympathetic and parasympathetic components of the autonomic nervous system. It is characterised by special type of manual stroke which is applied to the connective tissue. These stretching maneuvers are applied to areas called \"reflex zones\", and create local, segmental and general therapeutic effects in the body.
The aim of this study is to investigate the effects of CTM on postmenopausal symptoms, menopause-specific quality of life (MENQoL) and insomnia.
For this purpose, 58 postmenopausal women ages between 45 to 65 who meet the inclusion criteria and volunteer to participate in the study will be randomly assigned to one of the two research arms, CTM or sham control. The women in the experimental group will receive CTM for 5-20 minutes, 3 times a week for 4 weeks. On the other hand, the women in the sham control group will receive superficial massage with the head of the therapeutic ultrasound device for 15 minutes at the same frequency for 4 weeks. In this study, primary outcome is menopausal symptom severity and it will be evaluated by \"Menopause Rating Scale\". Secondary outcomes are hot flash frequency, hot flash score (frequency X severity), menopause-specific quality of life, emotional status and insomnia. These outcomes will be assessed by daily diaries and the questionnaires \"Menopause-Specific Quality of Life Scale\", \"Depression-Anxiety-Stress 21 Scale\" and \"Insomnia Severity Index\".
The diaries will be filled out for one week (7 days each); at the baseline and just after the completion of the study. All other outcome measurements will be performed before and immediately after the study is completed. The results will be compared within groups and between two study groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connective tissue manipulation | Experimental | Other: Connective tissue manipulationConnective tissue manipulation will be applied to participants' back for 5-20 minutes, 3 times a week for 4 weeks in this group. |
| Superficial massage with the head of the therapeutic ultrasound device | Sham comparator | Other: Superficial massage with the head of the therapeutic ultrasound deviceSuperficial massage with the head of the therapeutic ultrasound device will be applied to participants' back for 15 minutes, 3 times a week for 4 weeks in this group. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between the 45 and 65 years,
- Being experienced at least 3 moderate or severe hot flashes, sweating or night sweats per day for at least 3 months,
- Being in the natural/spontaneous postmenopausal (amenorrhea for at least 12 months) period for less than 10 years,
- Having stable vital signs (heart rate, blood pressure),
- Volunteer to participate in the study,
Key exclusion criteria (7 listed)
- Neurological diseases,
- Uncontrolled systemic and metabolic diseases (uncontrolled diabetes mellitus, hypertension, etc.)
- History of cancer,
- History of surgical menopause,
- Obesity (BMI > 35 kg/m²),
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 |
|---|---|---|
| Connective tissue manipulationConnective tissue manipulation will be applied to participants' back for 5-20 minutes, 3 times a week for 4 weeks in this group. | Other | Connective tissue manipulation |
| Superficial massage with the head of the therapeutic ultrasound deviceSuperficial massage with the head of the therapeutic ultrasound device will be applied to participants' back for 15 minutes, 3 times a week for 4 weeks in this group. | Other | Superficial massage with the head of the therapeutic ultrasound device |
Primary outcome
Severity of menopausal symptoms
Time frame: Change in the severity of menopausal symptoms from baseline to at the end of the 4th week.
The severity of menopausal symptoms will be evaluated with the Menopause Rating Scale (MRS). MRS was developed to assess the severity of 11 symptoms associated with menopause. Each of the 11 symptoms may score between 0 (no symptoms) and 4 points (severe symptoms), depending on the perceived severity of the complaints. The total score of the MRS ranges between 0 (asymptomatic) and 44 (highest degree of complaints).
5 secondary outcomes
Frequency of vasomotor symptoms
Time frame: Change in the frequency of vasomotor symptoms from baseline to at the end of the 4th week.
Vasomotor symptom intensity
Time frame: Change in the vasomotor symptom score from baseline to at the end of the 4th week.
Quality of life associated with menopause
Time frame: Change in quality of life associated with menopause from baseline to at the end of the 4th week.
Level of psychological symptoms
Time frame: Change in the level of psychological symptoms from baseline to at the end of the 4th week.
Severity of insomnia
Time frame: Change in severity of insomnia from baseline to at the end of the 4th week.
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 25 Sep 2024.
- Background: PubMed 30401544Gracia CR, Freeman EW. Onset of the Menopause Transition: The Earliest Signs and Symptoms. Obstet Gynecol Clin North Am. 2018 Dec;45(4):585-597. doi: 10.1016/j.ogc.2018.07.002. Epub 2018 Oct 25.
- Background: PubMed 26921929Roberts H, Hickey M. Managing the menopause: An update. Maturitas. 2016 Apr;86:53-8. doi: 10.1016/j.maturitas.2016.01.007. Epub 2016 Jan 22.
- Background: PubMed 26316239Santoro N, Epperson CN, Mathews SB. Menopausal Symptoms and Their Management. Endocrinol Metab Clin North Am. 2015 Sep;44(3):497-515. doi: 10.1016/j.ecl.2015.05.001.
- Background: PubMed 28703650Cobin RH, Goodman NF; AACE Reproductive Endocrinology Scientific Committee. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY POSITION STATEMENT ON MENOPAUSE-2017 UPDATE. Endocr Pract. 2017 Jul;23(7):869-880. doi: 10.4158/EP171828.PS.
- Background: PubMed 24411158Holey LA, Dixon J. Connective tissue manipulation: a review of theory and clinical evidence. J Bodyw Mov Ther. 2014 Jan;18(1):112-8. doi: 10.1016/j.jbmt.2013.08.003. Epub 2013 Sep 8.
- Background: PubMed 29916944Fu P, Gibson CJ, Mendes WB, Schembri M, Huang AJ. Anxiety, depressive symptoms, and cardiac autonomic function in perimenopausal and postmenopausal women with hot flashes: a brief report. Menopause. 2018 Dec;25(12):1470-1475. doi: 10.1097/GME.0000000000001153.
- Background: PubMed 22230663Guttuso T Jr, DiGrazio WJ, Reddy SY. Review of hot flash diaries. Maturitas. 2012 Mar;71(3):213-6. doi: 10.1016/j.maturitas.2011.12.003. Epub 2012 Jan 9.
- Background: PubMed 11910611Schneider HP, Heinemann LA, Rosemeier HP, Potthoff P, Behre HM. The Menopause Rating Scale (MRS): reliability of scores of menopausal complaints. Climacteric. 2000 Mar;3(1):59-64. doi: 10.3109/13697130009167600.
- Background: PubMed 7726811Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
- Background: PubMed 21532953Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.
- Background: PubMed 8844630Hilditch JR, Lewis J, Peter A, van Maris B, Ross A, Franssen E, Guyatt GH, Norton PG, Dunn E. A menopause-specific quality of life questionnaire: development and psychometric properties. Maturitas. 1996 Jul;24(3):161-75. doi: 10.1016/s0378-5122(96)82006-8.
- Derived from this study: PubMed 39522476Albayrak G, Cagliyan Turk A, Ozgul S. Effects of connective tissue massage on physical and emotional symptoms, insomnia, and quality of life in postmenopausal women: A randomized, sham-controlled trial. Maturitas. 2025 Jan;191:108149. doi: 10.1016/j.maturitas.2024.108149. Epub 2024 Nov 7.
- Individual participant dataSharing planned: No
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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.
Serap Özgül, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connective tissue manipulation and Superficial massage with the head of the therapeutic ultrasound device in people with Menopause Syndrome, run by Hacettepe 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 6 inclusion and 7 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 25 Sep 2024. 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. Some participants in this study may receive a placebo. 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?
Severity of menopausal symptoms (time frame: Change in the severity of menopausal symptoms from baseline to at the end of the 4th week.). 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 NCT05293860, which also lists 12 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 25 Sep 2024.