- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01904578
The Efficacy of Acupressure on Sleep Quality in Menopausal Women
July 21, 2013 updated by: Zahra Abedian, Mashhad University of Medical Sciences
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 2
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
41 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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,
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: true acupressure
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.
|
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 Comparator: sham acupressure
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.
|
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
|
No Intervention: control
The control group only received the weekly control of blood pressure and speech communication .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 ).
|
4 consecutive weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
July 7, 2012
First Submitted That Met QC Criteria
July 17, 2013
First Posted (Estimate)
July 22, 2013
Study Record Updates
Last Update Posted (Estimate)
July 23, 2013
Last Update Submitted That Met QC Criteria
July 21, 2013
Last Verified
February 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- treatment (treatment pelvic inflammatuary disease)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Poor Quality Sleep
-
University GhentEuropean CommissionEnrolling by invitation
-
Cerebra MedicalEkosi Health CentreRecruiting
-
Wecare Probiotics Co., Ltd.Completed
-
National Taiwan University HospitalCompleted
-
University of SaskatchewanCompleted
-
Columbia UniversityCompletedPoor Quality SleepUnited States
-
Dr. Zannatun Nahar NuriCompletedPoor Sleep QualityBangladesh
-
Emory UniversitySunovionCompletedPoor Quality Sleep
-
Northumbria UniversityCompletedSleep | Mood | Poor Quality Sleep | Good Sleep HabitUnited Kingdom
Clinical Trials on true accupressure
-
Istanbul Aydın UniversityIstanbul University; Acibadem UniversityRecruitingOpioid-induced Bowel Dysfunction | Constipation Drug InducedTurkey
-
Yale UniversityNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingFirearm InjuryUnited States
-
It's My Community InitiativeCompletedFather-Child RelationsUnited States
-
Indonesia UniversityCompletedUrinary RetentionIndonesia
-
Woung-Ru TangHarapan Bangsa University; RS Prof. Dr. Margono Soekardjo PurwokertoCompleted
-
Burke Medical Research InstituteTerminated
-
Xuanwu Hospital, BeijingUnknownAlzheimer's DiseaseChina
-
Tianjin Third Central HospitalRecruitingHepatocellular Cancer | Prognosis | Microwave Ablation | Microwave Spherical AblationChina
-
Cairo UniversityRecruitingObesity | Tinnitus, Subjective | LipidsEgypt