The Effect of Acupressure Application on Menopausal Symptoms

Sponsor

Adiyaman University Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04520542

Collaborator

(none)

120

Enrollment

Location

Arms

8.7

Actual Duration (Months)

13.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study was conducted randomly controlled to determine the effect of acupressure application on menopausal complaints among women who applied to Cancer Early Diagnosis and Screening Center.

Condition or Disease	Intervention/Treatment	Phase
Menopausal Syndrome	Other: Acupressure Application	N/A

Detailed Description

Research, between September 2019 and February 2020 of cancer in the body healthy life center in the east of the provincial center of Turkey was held by early diagnosis and screening center that refer to women.

The Universe and Sample of the Research The universe of the study consisted of women who applied to cancer early diagnosis and screening center for examination for any reason.

The calculation of the sample size of the study was determined according to the studies in which non-pharmacological methods were used to cope with menopausal symptoms. The calculation was determined according to the effect size of 0.5 in a moderate level, considering the effect size ranging between (0.25-0.83) reported by the studies on the subject.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Investigator)

Primary Purpose:

Supportive Care

Official Title:

The Effect of Acupressure Application on Menopausal Symptoms

Actual Study Start Date :

Jun 5, 2019

Actual Primary Completion Date :

Sep 13, 2019

Actual Study Completion Date :

Feb 25, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: acupressure The application was performed on the determined acupressure points by considering the direction of the meridian in a certain order. It was performed with the administration order of Spleen 6th point (SP 6) and Large Intestine 4th point (Li 4). In total, the administration was performed with 4 acupressure points including 2 points in the upper/lower extremity along with the parallel points in each intervention. Each acupressure point was massaged for 30 seconds to provide circulation before the pressure. After the massage, consecutive pressures were applied for 90 seconds. In each intervention, a total of 8-minute sessions were applied to 4 points as 2 minutes for each point. Consecutive pressures were applied on a frequency that did not disturb the women, did not cause pain, and had a soothing effect. Until the end of the intervention it was continued 2 times a week, 16 times in total in 8 weeks.	Other: Acupressure Application Acupressure was administered in a semi-sitting or supine position where the woman felt comfortable and the researcher could perform the practice comfortably to the acupressure points. The application was performed on the determined acupressure points by considering the direction of the meridian in a certain order. It was performed with the administration order of Spleen 6th point (SP 6) and Large Intestine 4th point (Li 4). In total, the administration was performed with 4 acupressure points including 2 points in the upper/lower extremity along with the parallel points in each intervention.
No Intervention: Control Group no intervation

Arm

Intervention/Treatment

Experimental: acupressure

The application was performed on the determined acupressure points by considering the direction of the meridian in a certain order. It was performed with the administration order of Spleen 6th point (SP 6) and Large Intestine 4th point (Li 4). In total, the administration was performed with 4 acupressure points including 2 points in the upper/lower extremity along with the parallel points in each intervention. Each acupressure point was massaged for 30 seconds to provide circulation before the pressure. After the massage, consecutive pressures were applied for 90 seconds. In each intervention, a total of 8-minute sessions were applied to 4 points as 2 minutes for each point. Consecutive pressures were applied on a frequency that did not disturb the women, did not cause pain, and had a soothing effect. Until the end of the intervention it was continued 2 times a week, 16 times in total in 8 weeks.

Other: Acupressure Application

Acupressure was administered in a semi-sitting or supine position where the woman felt comfortable and the researcher could perform the practice comfortably to the acupressure points. The application was performed on the determined acupressure points by considering the direction of the meridian in a certain order. It was performed with the administration order of Spleen 6th point (SP 6) and Large Intestine 4th point (Li 4). In total, the administration was performed with 4 acupressure points including 2 points in the upper/lower extremity along with the parallel points in each intervention.

No Intervention: Control Group

no intervation

Outcome Measures

Primary Outcome Measures

Effect of Acupressure Application on Menopausal Symptoms [8 week]
Menopause Rating Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

in the 45-65 age range.

Exclusion Criteria:

receiving pharmacological treatment related to menopause,
having a communication problem,
have a hearing problem
It is the presence of tissue deformity in its extremities.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Didem Simsek Kucukkelepce	Adiyaman		Turkey	02100

Sponsors and Collaborators

Adiyaman University Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Didem Kucukkelepce, Lokman Hekim University, Adiyaman University Research Hospital

ClinicalTrials.gov Identifier:

NCT04520542

Other Study ID Numbers:

Lokman Hekim Universty

First Posted:

Aug 20, 2020

Last Update Posted:

Aug 20, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 20, 2020