- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06225102
The Effect of Kegel Exercise in Nursing Students With Primary Dysmenorrhoea
The Effect of Kegel Exercise on Menstruation Symptom, Severity of Dysmenorrheic Symptoms and Quality of Life in Nursing Students With Primary Dysmenorrhea: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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
- VAS total scores in interventions involving kegel exercise training and regular kegel exercise are lower than control interval rates (H1).
- 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).
- 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).
- 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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gümüşhane, Turkey
- Gümüşhane University, Faculty of Health Sciences, Department of Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental group
The intervention group was first given training on the definition of kegel exercises, diagnostic criteria, treatment, benefits and how to do kegel exercises on the Zoom platform. A second meeting was held for the participants of the initiative group who could not attend this training. At the same time, a message was sent to the WhatsApp application group where the intervention group was located three times a day by the researchers to remind them to do kegel exercises in the morning, noon and evening. |
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No Intervention: control group
No intervention was made in the control group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Personal Information Form
Time Frame: one week
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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.
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one week
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Visual Analogue Scale
Time Frame: one week
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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
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The Menstrual Symptom Scale
Time Frame: Three months
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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
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Three months
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The Severity of Dysmenorrheic Symptoms
Time Frame: Three months
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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
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Three months
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The Quality of Life Scale
Time Frame: Three months
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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.
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Three months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: RUVEYDE AYDIN, Ondokuz Mayıs University
- Principal Investigator: ÖZGE PALANCI AY, Gümüşhane Universıty
- Principal Investigator: SONGÜL AKTAŞ, Karadeniz Technical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GU-SBF-OPA-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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