The Efficacy of Acupressure on Sleep Quality in Menopausal Women

Poor Quality Sleep Clinical Trial

Official title:

The Effect of Acupressure on Sleep Quality in Menopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01904578
• Other study ID #: treatment
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 7, 2012
• Last updated: July 21, 2013
• Start date: February 2010
• Est. completion date: February 2011

Study information

• Verified date: February 2010
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 41 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Poor Quality Sleep

Intervention

Other:
• 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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment of quality of sleep	treatment of quality of sleep by acupressure.sleep quality was measured with Pittsburgh Sleep Quality Index (PSQI ).	4 consecutive weeks	No