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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06225102
Other study ID # GU-SBF-OPA-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date July 31, 2021

Study information

Verified date January 2024
Source Gümüshane University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, it was aimed to determine the effect of kegel exercise on menstruation symptoms, severity of dysmenorrheic symptoms and quality of life in nursing students with primary dysmenorrhea. The study was conducted as a single-blind randomized controlled trial.


Description:

The study was conducted in a single-blind randomized controlled trial with 89 nursing students with primary dysmenorrhea. The experimental group was given kegel exercise training online, and after the training, a message was sent to remind them to do kegel exercises three times a day during the follow-up. No intervention was made in the control group. Hypotheses of the Research 1. VAS total scores in interventions involving kegel exercise training and regular kegel exercise are lower than control interval rates (H1). 2. The total score of the Menstruation Symptom Scale within the participants who participated in kegel exercise training and regular kegel exercise was recorded, at lower rates than the distribution of control intervals (H1). 3. The Severity of Dysmenorrheic Symptoms in participants who participated in kegel exercise training and regular kegel exercise interventions were lower than the distribution of control intervals (H1). 4. The total scores of the Quality of Life Scale among those who participated in kegel exercise training and regular kegel exercises were higher than the proportions of the controlled rankings (H1).


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date July 31, 2021
Est. primary completion date July 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - be between the ages of 18-25 - Giving 6 points or more to the least menstruation pain on the day that individuals experience the most severe dysmenorrhea symptoms (VAS) out of 10 points on the VAS Visual Pain Scale - Being Nulliparous (never giving birth) - Regular menstruation for the last six months - Not having any gynecological diagnosis - Not having had a gynecological operation - Volunteering to participate in the study Exclusion Criteria: - Being a man - Being married - Being diagnosed with secondary dysmenorrhea - Giving menstruation pain less than 6 points out of 10 on the VAS Visual Pain Scale. - Taking painkillers 12 hours before the assessments.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Kegel Exercise
Before teaching Kegel exercises, it was recommended that the person empty his bladder and wear comfortable clothing. It was said that the person should extend his legs straight while exercising and not to contract his leg, hip and abdominal muscles and not to hold his breath while the pelvic floor muscles contract. The relevant muscles were told to contract for 10 seconds and then relax for 10 seconds. The person was also asked to do the exercises during daily activities. Exercise was implemented regularly 3 times a day (minimum 30-45 exercises) in the morning, noon and evening.

Locations

Country Name City State
Turkey Gümüshane University, Faculty of Health Sciences, Department of Nursing Gümüshane

Sponsors (1)

Lead Sponsor Collaborator
Gümüshane University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Personal Information Form It was prepared in line with the literature. The form consists of a total of 25 questions, including information about socio-demographic information, pain during menstrual period, vaginal discharge characteristics, and practices regarding menstrual quantity. one week
Primary Visual Analogue Scale It was used to evaluate the pain intensity of individuals during their menstrual period.
Individuals were asked to mark their pain level on a 10-centimeter (cm) horizontal line, meaning "0 (no pain)" and "10 (most severe pain)."
Individuals responded by thinking about the pain they experienced during the first 3 days of their first, second, and third menstrual cycles.
one week
Primary The Menstrual Symptom Scale The scale consists of 22 items and is a five-point Likert type. Items 1-13 belong to "Negative effects/somatic complaints" sub-dimension, items 14-19 belong to "Menstrual pain symptoms" sub-dimension and items 20-22 belong to "Coping methods" sub-dimension. The Menstrual Symptom Scale score is calculated by averaging the total score of the items in the scale. Participants are asked to assign a number between 1 (never) and 5 (always) to the symptoms they experience related to menstruation. An increase in the mean score indicates an increase in the severity of menstrual symptoms. The scale has three sub-dimensions. The score obtained from the sub-dimensions is calculated by averaging the total score of the items in the sub-dimensions. An increase in the mean score for the sub-dimensions indicates an increase in the severity of menstrual symptoms related to that sub-dimension. Cronbach's Alpha value of the scale is 0.86 Three months
Primary The Severity of Dysmenorrheic Symptoms The presence and magnitude of dysmenorrhoeic symptoms were assessed using this Likert-type scale (none = 0; mild = 1; moderate = 2; and severe = 3). The dimensions assessed by the scale are: Colicky pain in the lower abdomen, bloating, irritability, depression pain or tenderness in the breasts, back pain, gastrointestinal disorders headache, leg oedema Three months
Primary The Quality of Life Scale Item-total score correlations were calculated between 0.47-0.88. It is not possible to obtain a total score for the Short Form-36 quality of life scale. Instead, summary scores can be obtained for the physical and mental components of health in the Short Form-36 scale. Physical health components are physical function, physical role, pain and general health perception subscales, while mental health components are vitality, social function, emotional role and mental health subscales. In the summary scores, the lowest score is "0" and the highest score is "100" and a high score indicates good health status. Three months
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