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Acupressure and Training for Coping With PMS

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ClinicalTrials.gov Identifier: NCT03899207
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Didem Kucukkelepce, Adiyaman University Research Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Premenstrual Syndrome Acupressure Other: training +acupressure Other: training Not Applicable

Detailed 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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomize control trail
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Adiyaman University School of Health
Actual Study Start Date : June 30, 2017
Actual Primary Completion Date : November 20, 2017
Actual Study Completion Date : April 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: training +acupressure
In the training+acupressure group, 10 women were excluded from the study since they could not participate in acupressure application at different times, 2 women were excluded since they had menstrual irregularities and 4 women were excluded since they could not be contacted.
Other: 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.

Experimental: training
In the training group, 4 women were excluded since they did not participate in the reminder training, 1 woman was excluded since she had menstrual irregularities, 3 women were excluded since they wanted to withdraw from the study and 3 women were excluded from the study since they could not be contacted.
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

No Intervention: control
In the control group, 4 women were excluded from the study since they could not be reached and 5 women were excluded since they did not agree to participate in the posttest.



Primary Outcome Measures :
  1. The Effects of Health Belief Model-Based Training for Coping with Premenstrual Syndrome and Acupressure on Premenstrual Symptoms and Quality of Life [ Time Frame: 10 month ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:

who did not meet the criteria for inclusion in research


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899207


Locations
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Turkey
DİDEM
Adıyaman, Turkey, 02100
ınönü Universty
Malatya, Turkey, 02100
Sponsors and Collaborators
Adiyaman University Research Hospital
Investigators
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Principal Investigator: Didem Simsek Kucukkelepce, phd World Health Organization

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Responsible Party: Didem Kucukkelepce, Adiyaman Universty, Adiyaman University Research Hospital
ClinicalTrials.gov Identifier: NCT03899207     History of Changes
Other Study ID Numbers: Adiyaman Universty
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Premenstrual Syndrome
Menstruation Disturbances
Pathologic Processes