Hot FlashesPhase 3NCT01429636
Applied Relaxation (AR) Technique Versus Its Modified Version for Treating Menopausal Symptoms
A Phase 3 study testing Modified Relaxation (MR) and Applied Relaxation (AR) in people with Hot Flashes and Night Sweats, run by Chiang Mai University at 1 site in Thailand.
Trial summary
The purpose of this study is to demonstrate better efficacy and effectiveness of modified applied relaxation technique over its original version for treating menopausal symptoms. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Hot Flashes, Night Sweats, Sleep Disturbances
- What is being tested?
- Modified Relaxation (MR) and Applied Relaxation (AR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2011to Dec 2011
- Phase
- Phase 3
- 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
- Perimenopausal women and postmenopausal women with either surgical or spontaneous menopause.
- Women who have at least 5 points of MRS score.
Who cannot join
- Women who are taking any hormone therapy for any reason in the past three months prior to entering the trails.
- Women with uncontrolled hypertension (>95mmHg diastolic pressure) or daily use of sedatives, tranquilizer or antidepressant medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 Study of Applied Relaxation (AR) Technique That Treating Menopausal Symptoms
The purpose of this study is to demonstrate better efficacy and effectiveness of modified applied relaxation technique over its original version for treating menopausal symptoms.
Read the detailed description
Applied Relaxation (AR) is the most commonly used behavioral methods for treating menopausal symptoms. Many clinical trials reported that the technique effectively improved vasomotor and related symptoms. There is a strong evidence to support its continue use in clinical settings.
However, the original AR technique is too cumbersome. It involves intensive training once a week for 12 consecutive weeks. Each weekly session takes 60 minutes, and subjects are requested to do self-practice at home for at least 15-20 minutes/day. As such, >25% of recruited subjects drop out from the training course. The investigators have modified the original AR technique by reducing the duration of training to only once, lasting 60 minutes. Participants are requested to do self-practice at home for 15-20 minutes/day as in the original technique. Instead of coming to a weekly class, the investigators use telephone to communicate with the subjects once a week for 12 consecutive weeks. A preliminary study showed all 10 recruited subjects remained in the study (MR; modified relaxation technique) until completion. They all reported dramatic improvement in their vasomotor symptoms.
In this study, the investigators propose to compare our modified version of AR with the original method in a randomized controlled clinical trial. The subjects will be Thai menopausal women with vasomotor symptoms. The main outcomes are the reduction in the MRS score (intensity of hot flushes, night sweats and sleep disturbances) among those who remain in the program at the end of the study (efficacy evaluation). As nearly all patients will remain in the MR group, while >25% of those in the AR group will be expected to drop out from the study, the investigators should be able to demonstrate a superiority of MR over AR in terms of effectiveness as well.
- Conditions
- Hot Flashes, Night Sweats, Sleep Disturbances
- Being tested
- Modified Relaxation (MR), Applied Relaxation (AR)
- Keywords
- perimenopause, postmenopause, vasomotor symptoms, relaxation
- Medical subject headings
- Hot Flashes, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Relaxation (MR)Behavioural
Also called Behavioral relaxation
The MR technique is modified from the AR technique that will require participants to attend only 1 session, lasting 60 minutes. After the training session, participants will be given a hand-out on MR. They will continue to practice MR at home once a day for 15-20 minutes during their leisure times, at least 5 days a week for the whole 12 weeks of the follow-up period.
Applied Relaxation (AR)Behavioural
Also called Behavioral Applied Relaxation
Participants will receive 12 sessions AR training. After that they will asked to practice at home once a day for 15-20 minutes during their leisure times, at least 5 days a week for the whole 12 weeks of the follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| Applied Relaxation (AR) | Experimental | Not described Receives: Behavioral: Applied Relaxation (AR) |
| Modified Relaxation (MR) | Experimental | Not described Receives: Behavioral: Modified Relaxation (MR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in global scores of Menopausal Rating Scale (MRS).
MRS measure after intervention at 1, 2 and 3 months for follow-up.
Measured: 12 weeks
Secondary outcomes (3)
Change in the frequency and severity of hot flushes.
Measure the frequency and severity of hot flushes after intervention at 1, 2 and 3 months.
Measured: 12 weeks
Change in the frequency and severity of night sweats.
Measure the frequency and severity of night sweats after intervention at 1, 2, and 3 months.
Measured: 12 weeks
Change in the frequency and severity of sleep disturbances.
Measure the frequency and severity of sleep disturbances after intervention at 1, 2, and 3 months.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suprawita Saensak, Chiang Mai University
- Investigators
- Suprawita - Saensak, PhDcandidate, Principal investigator, PhD in Clinical Epidemiology Program, Faculty of Medicine, Chiang Mai University (Thailand)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429636
- Sponsor's protocol ID
- ARMR-Sympts
- Status last verified
- Dec 2011
- First submitted
- 1 Sep 2011
- Last updated
- 30 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Applied Relaxation (AR) Technique That Treating Menopausal Symptoms
- ClinicalTrials.gov ID
- NCT01429636
- Acronym / sponsor ID
- ARMR-Sympts
- Conditions
- Hot Flashes, Night Sweats, Sleep Disturbances
- Keywords
- perimenopause, postmenopause, vasomotor symptoms, relaxation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Sep 2011 (estimated)
- 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 demonstrate better efficacy and effectiveness of modified applied relaxation technique over its original version for treating menopausal symptoms.
Detailed description
Applied Relaxation (AR) is the most commonly used behavioral methods for treating menopausal symptoms. Many clinical trials reported that the technique effectively improved vasomotor and related symptoms. There is a strong evidence to support its continue use in clinical settings.
However, the original AR technique is too cumbersome. It involves intensive training once a week for 12 consecutive weeks. Each weekly session takes 60 minutes, and subjects are requested to do self-practice at home for at least 15-20 minutes/day. As such, >25% of recruited subjects drop out from the training course. The investigators have modified the original AR technique by reducing the duration of training to only once, lasting 60 minutes. Participants are requested to do self-practice at home for 15-20 minutes/day as in the original technique. Instead of coming to a weekly class, the investigators use telephone to communicate with the subjects once a week for 12 consecutive weeks. A preliminary study showed all 10 recruited subjects remained in the study (MR; modified relaxation technique) until completion. They all reported dramatic improvement in their vasomotor symptoms.
In this study, the investigators propose to compare our modified version of AR with the original method in a randomized controlled clinical trial. The subjects will be Thai menopausal women with vasomotor symptoms. The main outcomes are the reduction in the MRS score (intensity of hot flushes, night sweats and sleep disturbances) among those who remain in the program at the end of the study (efficacy evaluation). As nearly all patients will remain in the MR group, while >25% of those in the AR group will be expected to drop out from the study, the investigators should be able to demonstrate a superiority of MR over AR in terms of effectiveness as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Applied Relaxation (AR) | Experimental | Behavioral: Applied Relaxation (AR) |
| Modified Relaxation (MR) | Experimental | Behavioral: Modified Relaxation (MR) |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Perimenopausal women and postmenopausal women with either surgical or spontaneous menopause.
- Women who have at least 5 points of MRS score.
Key exclusion criteria (2 listed)
- Women who are taking any hormone therapy for any reason in the past three months prior to entering the trails.
- Women with uncontrolled hypertension (>95mmHg diastolic pressure) or daily use of sedatives, tranquilizer or antidepressant medication.
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 |
|---|---|---|
| Modified Relaxation (MR)Also: Behavioral relaxationThe MR technique is modified from the AR technique that will require participants to attend only 1 session, lasting 60 minutes. After the training session, participants will be given a hand-out on MR. They will continue to practice MR at home once a day for 15-20 minutes during their leisure times, at least 5 days a week for the whole 12 weeks of the follow-up period. | Behavioural | Modified Relaxation (MR) |
| Applied Relaxation (AR)Also: Behavioral Applied RelaxationParticipants will receive 12 sessions AR training. After that they will asked to practice at home once a day for 15-20 minutes during their leisure times, at least 5 days a week for the whole 12 weeks of the follow-up period. | Behavioural | Applied Relaxation (AR) |
Primary outcome
Changes in global scores of Menopausal Rating Scale (MRS).
Time frame: 12 weeks
MRS measure after intervention at 1, 2 and 3 months for follow-up.
3 secondary outcomes
Change in the frequency and severity of hot flushes.
Time frame: 12 weeks
Change in the frequency and severity of night sweats.
Time frame: 12 weeks
Change in the frequency and severity of sleep disturbances.
Time frame: 12 weeks
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 30 Dec 2011.
- NIH is the nation's medical research agency-supporting scientific studies that turn discovery into health.Link provided by the sponsor.
- PubMed comprises more than 21 million citations for biomedical literature from MEDLINE, life science journals, and online books.Link provided by the sponsor.
- Elsevier is committed to making genuine contributions to the science and health communities.Link provided by the sponsor.
- The Journal of The North American Menopause Society is a peer-reviewed scientific journal owned by NAMS and published by Lippincott Williams \& Wilkins (LWW).Link provided by the sponsor.
- The International Journal of Clinical and Health Psychology.Link provided by the sponsor.
- The world's largest collection of STM books, journals, protocol and reference works.Link provided by the sponsor.
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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.
Suprawita - Saensak, PhDcandidate principal investigator
PhD in Clinical Epidemiology Program, Faculty of Medicine, Chiang Mai University (Thailand)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Modified Relaxation (MR) and Applied Relaxation (AR) in people with Hot Flashes and Night Sweats, run by Chiang Mai University at 1 site in Thailand.
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 2 inclusion and 2 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 30 Dec 2011. 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 Thailand. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in global scores of Menopausal Rating Scale (MRS). (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2011.