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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03899207
Other study ID # Adiyaman Universty
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 30, 2017
Est. completion date April 20, 2018

Study information

Verified date August 2019
Source Adiyaman University Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study was conducted to determine the effect of acupressure and training, given to women under the guidance of health belief model for coping with premenstrual syndrome, on the premenstrual symptoms and quality of life.

This study was conducted to as a randomized controlled trial. The population of the study was composed of all women with PMS registered in FHCs no. 4 and 14 located in the city center. The sample of the study consisted of women including 51 women in training +acupressure group, 55 women in training group and 57 women in control group. The data were collected with Participant Information Form, PMSS and WHOQOL-BREF in the study. Training and acupressure were administered to the acupressure + training group. Only the training for coping with premenstrual syndrome was given to the training group. The data collection forms were reapplied to all groups 12 weeks after the pretest.


Description:

Premenstrual Syndrome is an important collection of symptoms affecting approximately one-fifth of women in reproductive age.

Acupressure is an intervention found in the nursing intervention system and defined as applying constant and powerful pressure on certain/specific points of the body in order to reduce pain, provide relaxation and relief, and to prevent or reduce nausea. Many studies conducted in gynecology have shown that acupressure decreased menstrual distress, premenstrual symptoms, back pain in women experiencing dysmenorrhea, labor pain and nausea and vomiting during pregnancy. In addition, it was shown in the studies that training given for PMS decreased the premenstrual symptoms


Recruitment information / eligibility

Status Completed
Enrollment 199
Est. completion date April 20, 2018
Est. primary completion date November 20, 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

Having regular menstruation (between 21-35 days),

not having any psychiatric diagnosis or any gynecological diseases

not using contraceptives,

not having tissue deformity in the extremities.

Exclusion Criteria:

having any psychiatric diagnosis having any gynecological diseases

Study Design


Related Conditions & MeSH terms


Intervention

Other:
training +acupressure
.Training+acupressure group; received training for coping with PMS prepared under the guidance of HBM and "The Booklet of Training for Coping with Premenstrual Symptoms" including information about the training given. In addition to the training, acupressure was applied by the researcher twice a week and 24 times in total. Acupressure application was continued with the same frequency until the end of the study (24 times in total for 3 months). One month after the first home visit, reminder training for coping with premenstrual symptoms was given to the women
training
Training Group; received the training for coping with PMS prepared under the guidance of HBM and "The Booklet of Training for Coping with Premenstrual Symptoms" including information about the training given. One month after the first home visit, reminder training was given to the women.

Locations

Country Name City State
Turkey DIDEM Adiyaman
Turkey inönü Universty Malatya

Sponsors (1)

Lead Sponsor Collaborator
Adiyaman University Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Effects of Health Belief Model-Based Training for Coping with Premenstrual Syndrome and Acupressure on Premenstrual Symptoms and Quality of Life The premenstrual syndrome scale,The lowest score to be taken from the scale is 44 and the highest score is 220. High score shows an increase in the intensity of the symptoms of premenstrual syndrome. If the total scale score is higher than 50% (110) of the highest score (220) in PMS scale, PMS is considered as "present".In the calculation of WHOQOL-BREF scoring, 1st and 2nd items are evaluated independently while the answers obtained from the 3rd, 4th, 26th and 27th questions are reversely scored since they indicate negative statements. The scale does not have a total score. Higher scores obtained from the subscales of the scale indicate that the quality of life level is high. 10 month
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