The Efficacy of Acupressure on Sleep Quality in Menopausal Women

NCT ID: NCT01904578

Last Updated: 2013-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-02-28

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

true accupressure

Intervention Type: OTHER

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 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.

Group Type: SHAM_COMPARATOR

sham acupressure

Intervention Type: OTHER

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

control

The control group only received the weekly control of blood pressure and speech communication .

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

true accupressure

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.

Intervention Type: OTHER

sham acupressure

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 41 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mashhad University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Zahra Abedian

Instructor of Midwifery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

treatment

Identifier Type: -

Identifier Source: org_study_id