This study was to evaluate the effectiveness of acupressure on sleep quality of postmenopausal women. This double blind randomized clinical trial was performed on 105 qualified menopausal women at the age of 41-65 years, spending at least 12 months after amenorrhea, getting a score higher than 5 from the Pittsburgh Sleep Quality Index (PSQI). The participant with emotional stress during the last 6 months, taking hormonal drugs during 3 last months, using herbal medicine to improve the menopausal symptoms excluded. Sleep quality was measured with PSQI. In the first stage, samples were selected by using a systematic method and in the second one, they were randomly assigned to three groups: acupressure (n=37), sham acupressure (n=36) and control groups (n=32). These interventions were carried out for 4 consecutive weeks each night (except Fridays). 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 performed1- 2 hours before sleep. Circular massage was performed with a 1 Cm circle diameter on the points of 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 . Non-acupoints, which were 1 to 3 CUN (Chinese unit of length) away from true acupoints were used in sham acupressure group. Whereas only conversation was used in the control group. Imrovement of sleep quality was assessed at the end of the follow up period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013100614910N1
Registration date:2014-01-21, 1392/11/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-21, 1392/11/01
Registrant information
Name
Zahra Abedian
Name of organization / entity
Mashhad University of Medical Science, School of Nursing & Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 1511
Email address
abedianz@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research vice chancellor, Mashhad University of Medical Science.
Expected recruitment start date
2009-12-29, 1388/10/08
Expected recruitment end date
2010-05-10, 1389/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on sleep quality in menopausal women in Mashhad: A Randomized Clinical Trial
Public title
The effect of acupressure on sleep quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria :spending at least 12 months after amenorrhea or Follicle Stimulating Hormone (FSH) serum level ≥ 40(1 year menopause); healthy of the pressure points, having a full conscious and also having an acceptable ability of listening and speaking to receive training and doing the self- care techniques at home; no having 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 emotional stress during the last 6 months ; 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; body mass index (BMI) higher than 30; having the moderate and severe depression based on Beck Depression Inventory; feeling of severe fatigue and anxiety; having circular job specially night job; lack of cooperation with researchers
Age
From 41 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
clinicaltrials.gov
Secondary trial Id
NCT01904578
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Science
Street address
Daneshgah street, Mashhad,Iran
City
Mashhad
Postal code
Approval date
2010-01-13, 1388/10/23
Ethics committee reference number
88410
Health conditions studied
1
Description of health condition studied
sleep quality
ICD-10 code
G47.9
ICD-10 code description
Sleep disorder, unspecified
Primary outcomes
1
Description
sleep quality in menopausal women
Timepoint
before & after interveantion
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)
Secondary outcomes
empty
Intervention groups
1
Description
Acupressure group: They were asked to massage the effective pressure points as a self-care method at home. The points 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 was done 1 to 2 hours before sleeping, each night (except Fridays) by circular massage with a 1 Cm circle diameter for 4 weeks. Participants were trained for the force of finger pressure. They needed to feel the full pressure of approximately 3-4 kg on the points but no feeling of pain.
Category
Treatment - Other
2
Description
Sham acupressure group: They were asked to massage the sham pressure points as a self-care method at home. Non-acupoints, which were 1 to 3 CUN (Chinese unit of length) away from true acupoints(Shenmen, Sanyinjiao, Fengchi, Yintang) were used in sham acupressure group. These points were out of the route of energy. Intervention was done 1 to 2 hours before sleeping, each night (except Fridays) by circular massage with a 1 Cm circle diameter for 4 weeks. Participants were trained for the force of finger pressure. They needed to feel the full pressure of approximately 3-4 kg on the points but no feeling of pain.
Category
Treatment - Other
3
Description
The control group: They received the weekly control of blood pressure and speech communication for 4 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Population Research Center of Mashhad
Full name of responsible person
Zahra Abedian
Street address
School Nursing & Midwifery of Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Dr Tfaghodi
Street address
ِDaneshgah street, Mashhad, Iran
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad School of Nursing and Midwifery
Full name of responsible person
Zahra Abedian
Position
Instructor of Midwifery Administrator for Research Affairs
Other areas of specialty/work
Street address
Ebne-Sina street, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
abedianz@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Zahra Abedian
Position
MSc in midwifery
Other areas of specialty/work
Street address
Ebne- Sina Street Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
abedianz@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad School of Nursing and Midwifery
Full name of responsible person
Zahra Abedian
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
abedianz@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)