Poor Quality SleepPhase 2/3NCT01904578
The Efficacy of Acupressure on Sleep Quality in Menopausal Women
A Phase 2/3 study testing true accupressure in people with Poor Quality Sleep, run by Mashhad University of Medical Sciences.
Trial summary
Sleep disorder is a common problem in menopausal women and the decrease in the sleep leads to poor daily activity. Traditional Chinese acupressure is a noninvasive, effective and safe technique that can be easily taught to menopausal women so that they apply it as a self-care method and a manager of sleep disruption. Read more about this study
- Who is it for?
- Ages 41 to 65 years, women only
- Conditions the study is for
- Poor Quality Sleep
- What is being tested?
- true accupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Feb 2011
- Phase
- Phase 2/3
- 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 41 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- spending at least 12 months after amenorrhea or follicle stimulating hormone
- (FSH) Serum level ≥ 40,
- healthy of the pressure points,
- having a full consciousness
- having an acceptable ability of listening
- speaking to receive training
Show all 10Show fewer
- doing the self- care techniques at home,
- no mental and physical disorders,
- getting a score higher than 5 from the Pittsburgh Sleep Quality Index (PSQI)
- able to sit for about 30 minutes.
Who cannot join
- having specific eating diets,
- addicted to narcotic drugs,
- using the drugs causing sleep disorders,
- suffering from special disease,
- taking hormonal drugs during 3 last months,
- using herbal medicine to improve the menopausal symptoms,
Show all 11Show fewer
- BMI higher than 30,
- having the moderate and severe depression based on Beck Depression Inventory,
- feeling of severe tiredness/ fatigue and anxiety,
- having circular job specially night job
- lack of cooperation with researchers.
About this study
Official title: The Effect of Acupressure on Sleep Quality in Menopausal Women
Sleep disorder is a common problem in menopausal women and the decrease in the sleep leads to poor daily activity. Traditional Chinese acupressure is a noninvasive, effective and safe technique that can be easily taught to menopausal women so that they apply it as a self-care method and a manager of sleep disruption. The purpose of the present study was to evaluate the effectiveness of acupressure on sleep quality of postmenopausal women.This double blind randomized clinical trial was performed on 120 qualified menopausal women at the age of 41-65 years; and sleep quality was measured with Pittsburgh Sleep Quality Index (PSQI ).Participants were randomly assigned to an acupressure group, a sham acupressure group and a control group by two time randomized method (systematic and simple randomized). These interventions were carried out for 4 consecutive weeks. Participants in acupressure group and sham acupressure group learned to carry out acupressure technique as a self care at home with the simultaneous massage techniques that were to be performed 2 hours before sleep, whereas only conversation was used in the control group. The statistical software package for social science (SPSS) Version 17 was used for data analysis.
- Conditions
- Poor Quality Sleep
- Being tested
- true accupressure, sham acupressure
- Keywords
- Menopause, Sleep quality, Acupressure
- 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.
true accupressureOther
Four acupoints were chosen for subjects in the acupressure group. They were Shenmen on the wrist crease, Sanyinjiao point (SP6) on both feet, Fengchi on the hairline of the back neck (occipital area)and Yintang, at the top of the nose on the center line between the ends of the eyebrows.
sham acupressureOther
Non-acupoints, which were 1 to 3 traditional Chinese unit of length (CUN) away from true acupoints, were used in sham acupressure group.These points were out of the route of energy
| Study group | Role | What they receive |
|---|---|---|
| true acupressure | Experimental | Massage the effective pressure points as a self-care method at home [ Four acupoints were chosen for subjects in the acupressure group. They were Shenmen on the wrist crease, Sanyinjiao point (SP6) on both feet, Fengchi on the hairline of the back neck (occipital area)and Yintang, at the top of the nose on the centre line between the ends of the eyebrows] for 10 minutes. It was done 1 to 2 hours before sleeping, each night (except Fridays) by circular massage with a 1 Cm circle diameter. Receives: Other: true accupressure |
| sham acupressure | Sham comparator | Massage the sham pressure points as a self-care method at home for 10 minutes. It was done 1 to 2 hours before sleeping, each night (except Fridays) by circular massage with a 1 Cm circle diameter. Receives: Other: sham acupressure |
| control | No intervention | The control group only received the weekly control of blood pressure and speech communication . |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment of quality of sleep
treatment of quality of sleep by acupressure.sleep quality was measured with Pittsburgh Sleep Quality Index (PSQI ).
Measured: 4 consecutive weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startFeb 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Quality SleepStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Abedian, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904578
- Sponsor's protocol ID
- treatment
- Status last verified
- Feb 2010
- First submitted
- 7 Jul 2012
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure on Sleep Quality in Menopausal Women
- ClinicalTrials.gov ID
- NCT01904578
- Acronym / sponsor ID
- treatment
- Conditions
- Poor Quality Sleep
- Keywords
- Menopause, Sleep quality, Acupressure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 22 Jul 2013 (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.
Sleep disorder is a common problem in menopausal women and the decrease in the sleep leads to poor daily activity. Traditional Chinese acupressure is a noninvasive, effective and safe technique that can be easily taught to menopausal women so that they apply it as a self-care method and a manager of sleep disruption. The purpose of the present study was to evaluate the effectiveness of acupressure on sleep quality of postmenopausal women.This double blind randomized clinical trial was performed on 120 qualified menopausal women at the age of 41-65 years; and sleep quality was measured with Pittsburgh Sleep Quality Index (PSQI ).Participants were randomly assigned to an acupressure group, a sham acupressure group and a control group by two time randomized method (systematic and simple randomized). These interventions were carried out for 4 consecutive weeks. Participants in acupressure group and sham acupressure group learned to carry out acupressure technique as a self care at home with the simultaneous massage techniques that were to be performed 2 hours before sleep, whereas only conversation was used in the control group. The statistical software package for social science (SPSS) Version 17 was used for data analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| true acupressure | Experimental | Other: true accupressureMassage the effective pressure points as a self-care method at home [ Four acupoints were chosen for subjects in the acupressure group. They were Shenmen on the wrist crease, Sanyinjiao point (SP6) on both feet, Fengchi on the hairline of the back neck (occipital area)and Yintang, at the top of the nose on the centre line between the ends of the eyebrows] for 10 minutes. It was done 1 to 2 hours before sleeping, each night (except Fridays) by circular massage with a 1 Cm circle diameter. |
| sham acupressure | Sham comparator | Other: sham acupressureMassage the sham pressure points as a self-care method at home for 10 minutes. It was done 1 to 2 hours before sleeping, each night (except Fridays) by circular massage with a 1 Cm circle diameter. |
| control | No intervention | –The control group only received the weekly control of blood pressure and speech communication . |
Who may qualify
- Ages
- 41 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- spending at least 12 months after amenorrhea or follicle stimulating hormone
- (FSH) Serum level ≥ 40,
- healthy of the pressure points,
- having a full consciousness
- having an acceptable ability of listening
Key exclusion criteria (11 listed)
- having specific eating diets,
- addicted to narcotic drugs,
- using the drugs causing sleep disorders,
- suffering from special disease,
- taking hormonal drugs during 3 last months,
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 |
|---|---|---|
| true accupressureFour acupoints were chosen for subjects in the acupressure group. They were Shenmen on the wrist crease, Sanyinjiao point (SP6) on both feet, Fengchi on the hairline of the back neck (occipital area)and Yintang, at the top of the nose on the center line between the ends of the eyebrows. | Other | true acupressure |
| sham acupressureNon-acupoints, which were 1 to 3 traditional Chinese unit of length (CUN) away from true acupoints, were used in sham acupressure group.These points were out of the route of energy | Other | sham acupressure |
Primary outcome
treatment of quality of sleep
Time frame: 4 consecutive weeks
treatment of quality of sleep by acupressure.sleep quality was measured with Pittsburgh Sleep Quality Index (PSQI ).
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 23 Jul 2013.
Related trials for Poor Quality Sleep
Recruiting
The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps
Poor Sleep Quality, Leg Cramps, Nocturnal
Recruiting
The Impact of Overnight Active Temperature Regulation on the Gut Microbiome, Inflammation, and Circadian Rhythm.
Poor Sleep Quality, Gut Microbiome
Enrolling by invitation
SHLH for Urban Adolescents (Efficacy Trial)
Poor Quality Sleep
Not yet recruiting
Effects of Daily Avocado Consumption on Sleep and Skin Health in Postmenopausal Females
Poor Sleep Quality
Not yet recruiting
Improving Sleep Health for Asian Americans
Poor Sleep Quality, Short Sleep
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing true accupressure in people with Poor Quality Sleep, run by Mashhad University of Medical Sciences.
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 10 inclusion and 11 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 23 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
treatment of quality of sleep (time frame: 4 consecutive 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 23 Jul 2013.