Primary DysmenorrheaNCT06225102
The Effect of Kegel Exercise in Nursing Students With Primary Dysmenorrhoea
A study testing Kegel Exercise in people with Primary Dysmenorrhea, run by Gümüşhane Universıty at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Kegel Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gümüşhane University, Faculty of Health Sciences, Department of Nursing
Gümüşhane
About this study
Official title: 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
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.
Read the 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).
- Conditions
- Primary Dysmenorrhea
- Being tested
- Kegel Exercise
- Keywords
- PRIMARY DYSMENORHEA, Kegel exercise, Nursing students, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kegel ExerciseBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | 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. Receives: Behavioral: Kegel Exercise |
| control group | No intervention | No intervention was made in the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one week
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.
Measured: one week
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
Measured: Three months
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
Measured: Three months
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.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start1 Mar 2021
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The sample of the study consisted of 89 nursing students with primary dysmenorrhea (45 experimental group and 44 control group)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gümüşhane Universıty
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge PALANCI AY, Gümüşhane Universıty
- Investigators
- RUVEYDE AYDIN, Principal investigator, Ondokuz Mayıs UniversityÖZGE PALANCI AY, Principal investigator, Gümüşhane UniversıtySONGÜL AKTAŞ, Principal investigator, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225102
- Sponsor's protocol ID
- GU-SBF-OPA-01
- Status last verified
- Jan 2024
- First submitted
- 13 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06225102
- Acronym / sponsor ID
- GU-SBF-OPA-01
- Conditions
- Primary Dysmenorrhea
- Keywords
- PRIMARY DYSMENORHEA, Kegel exercise, Nursing students, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Gümüşhane UniversıtyUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The sample of the study consisted of 89 nursing students with primary dysmenorrhea (45 experimental group and 44 control group)
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: Kegel ExerciseThe 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. |
| control group | No intervention | –No intervention was made in the control group |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | experimental group |
Primary outcome
Personal Information Form
Time frame: one week
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.
Visual Analogue Scale
Time frame: one week
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.
The Menstrual Symptom Scale
Time frame: Three months
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
The Severity of Dysmenorrheic Symptoms
Time frame: Three months
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
The Quality of Life Scale
Time frame: Three months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Primary Dysmenorrhea
Not yet recruiting
Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
Primary Dysmenorrhea
Not yet recruiting
Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
Primary Dysmenorrhea (PD), Menstrual Pain
Recruiting
The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea
Dysmenorrhea, Primary Dysmenorrhea
Not yet recruiting
The Effect of Hydrogen-Rich Water on Dysmenorrhea and Menstrual Symptom Severity
Dysmenorrhea Primary
Not yet recruiting
Effect of Virtual Reality on Pain and Anxiety in Women With Dysmenorrhea
Primary Dysmenorrhea, Menstrual Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RUVEYDE AYDIN principal investigator
Ondokuz Mayıs University
ÖZGE PALANCI AY principal investigator
Gümüşhane Universıty
SONGÜL AKTAŞ principal investigator
Karadeniz Technical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kegel Exercise in people with Primary Dysmenorrhea, run by Gümüşhane Universıty at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Information Form (time frame: one week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.