Primary DysmenorrheaNCT06339918
Combined Effects of Kegel Exercises and 4-7-8 Breathing Technique in Primary Dysmenorrhea
A study testing KegelExercise and 4-7-8 breathing technique in people with Primary Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.
Trial summary
A randomized clinical trial will be conducted at Riphah International University QIE Campus in Lahore, using non-probability convenience sampling with 28 participants. Criteria include women aged 14-26, nulliparous, experiencing primary dysmenorrhea, with normal menstrual cycles and the ability to exercise… Read more about this study
- Who is it for?
- Ages 14 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- KegelExercise and 4-7-8 breathing technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2024to 5 Oct 2024
- 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 14 to 26 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Nulliparous women
- Women with a score greater than 4 on WALIDD primary dysmenorrhea intensity scale
- Women having a history of normal menstrual cycles that lasts 3-7 days and range from 21- 35 days.
- Ability to perform exercises independently
Who cannot join
- Women with very mild primary dysmenorrhea
- Women treated for ovarian cysts or other gynecological issues
- Women currently taking medication for dysmenorrhea
- History of any systemic illness
- A history of psychological conditions that could influence the perception of pain and functional activity.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University Clinic
Lahore, Punjab Province, 54700
About this study
Official title: Combined Effects of Kegel Exercises and 4-7-8 Breathing Technique on Pain Intensity, Symptom Severity and Functional Activity in Primary Dysmenorrhea
A randomized clinical trial will be conducted at Riphah International University QIE Campus in Lahore, using non-probability convenience sampling with 28 participants. Criteria include women aged 14-26, nulliparous, experiencing primary dysmenorrhea, with normal menstrual cycles and the ability to exercise independently. Group A will receive kegel exercises and 4-7-8 breathing techniques over 8 weeks, while Group B will only receive the breathing technique. Assessments will be done on menstrual cycle days, with follow-ups at weeks 4 and 8 using specific scales. Data will be analyzed using SPSS version 27.
Read the detailed description
This study will be a randomized clinical trial. Riphah International University QIE Campus in Lahore will serve as the site of data collecting and intervention services. Non-probability convenience sampling will be the method of sampling. The study's sample size will be 28 participants. Inclusion criteria for this study will be: women between ages 14-26 years, nulliparous women, with a score greater than 4 in WALIDD primary dysmenorrhea intensity scales, history of normal menstrual cycles that lasts 3-7 days and ranged from 21- 35 days, ability to perform exercises independently. Group A will be given kegel exercises as well as 4-7-8 breathing techniques for a total of 8 weeks with 4 sessions per week. Whereas, group B will be given the 4-7-8 breathing technique only. Initial assessment will be taken on the 3rd day of menstrual period. Follow-up assessment will be taken after week 4 post interventions and final assessment will be done after week 8 post intervention. WaLIDD primary dysmenorrhea intensity scale, Pain Self-Efficacy Questionnaire (PESQ), and Numeric Pain Rating Scale (NPRS) will be the data collecting instruments.
- Conditions
- Primary Dysmenorrhea
- Being tested
- KegelExercise, 4-7-8 breathing technique
- Keywords
- Kegel Exercises, Breathing Exercises, Relaxation Techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KegelExerciseOther
Kegel exercises (also called pelvic floor exercises)will be used to strengthen the pelvic floor muscles it will involve repeatedly contracting and relaxing the muscles that form part of the pelvic floor.
4-7-8 breathing techniqueOther
This can be performed in the following way: Participants taking part should locate a comfy spot to sit. Inhale to the count of 4. Hold their breath for 7 counts. To the count of 8, release air via their mouth.
| Study group | Role | What they receive |
|---|---|---|
| Kegel Exercise with4-7-8 Breathing technique group: | Experimental | GroupAwill be given the intervention of kegel exercises as well as 4-7-8 breathing techniques for about 15 minutes per session for a total of 8 weeks with 4 sessions per week. To perform kegel exercises, tighten pelvic floor muscles like trying to hold in urine and stool. 4-7-8 breathing Technique can be performed by telling the participant to inhale to the count of 4. Hold their breath for 7 counts. To the count of 8, release air via their mouth. Receives: Other: KegelExercise; Other: 4-7-8 breathing technique |
| 4-7-8 Breathing Technique group | Active comparator | In this group, we only perform the 4-7-8 Breathing Technique by telling the participant to inhale to the count of 4. Hold their breath for 7 counts. To the count of 8, release air via their mouth. Receives: Other: 4-7-8 breathing technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
TheNPRSisa popular patient-reported response scale is the NPRS. The most widely used form of the NPRS is the ordinal 11-point version (0-no pain, 10-most extreme pain). A line or bar that is horizontal is the standard format. The NPRS is anchored by phrases that describe extremes of pain severity.
Measured: up to 8 weeks
WALIDD Primary Dysmenorrhea Intensity Scale
WaLIDD stands for working ability, location, intensity, days of pain, dysmenorrhea. It is used to diagnose Primary dysmenorrhea as well its pain intensity and severity of symptoms. It is a new tool established and used in many researches and practices as a questionnaire to evaluate whether women are suffering from primary dysmenorrhea or not. The WaLIDD instrument is part of a confidential questionnaire that inquires about every factor to be examined, as well as details about age, menarche, menstrual cycle features, type and number of nonsurgical treatments used to manage dysmenorrhea, number of days of medical leave taken for dysmenorrhea.
Measured: up to 8 weeks
Pain Self-Efficacy Questionnaire (PSEQ)
The Pain Self-Efficacy Questionnaire (PSEQ) is a valid instrument that is widely used to evaluate a person's comfort level with chronic pain management. Rhe PSEQ measures self-efficacy beliefs in pain management and how important it is to comprehend how pain affects both functional and emotional elements of life.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Apr 2024
- Primary completion20 Sep 2024
- Study completion5 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nirmal Zahid, MS*, Principal investigator, Riphah International University, Lahore, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339918
- Sponsor's protocol ID
- REC/RCR & AHS/23/0570
- Status last verified
- Nov 2024
- First submitted
- 25 Mar 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abreu-Sanchez A, Parra-Fernandez ML, Onieva-Zafra MD, Ramos-Pichardo JD, Fernandez-Martinez E. Type of Dysmenorrhea, Menstrual Characteristics and Symptoms in Nursing Students in Southern Spain. Healthcare (Basel). 2020 Aug 26;8(3):302. doi: 10.3390/healthcare8030302.
PubMed 32858887Bernardi M, Lazzeri L, Perelli F, Reis FM, Petraglia F. Dysmenorrhea and related disorders. F1000Res. 2017 Sep 5;6:1645. doi: 10.12688/f1000research.11682.1. eCollection 2017.
PubMed 28944048Bakhsh H, Algenaimi E, Aldhuwayhi R, AboWadaan M. Prevalence of dysmenorrhea among reproductive age group in Saudi Women. BMC Womens Health. 2022 Mar 19;22(1):78. doi: 10.1186/s12905-022-01654-9.
PubMed 35305636Matsas A, Sachinidis A, Lamprinou M, Stamoula E, Christopoulos P. Vitamin Effects in Primary Dysmenorrhea. Life (Basel). 2023 Jun 1;13(6):1308. doi: 10.3390/life13061308.
PubMed 37374091
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Kegel Exercises and 4-7-8 Breathing Technique on Pain Intensity, Symptom Severity and Functional Activity in Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06339918
- Acronym / sponsor ID
- REC/RCR & AHS/23/0570
- Conditions
- Primary Dysmenorrhea
- Keywords
- Kegel Exercises, Breathing Exercises, Relaxation Techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 5 Oct 2024 (actual)
- First posted
- 1 Apr 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.
A randomized clinical trial will be conducted at Riphah International University QIE Campus in Lahore, using non-probability convenience sampling with 28 participants. Criteria include women aged 14-26, nulliparous, experiencing primary dysmenorrhea, with normal menstrual cycles and the ability to exercise independently. Group A will receive kegel exercises and 4-7-8 breathing techniques over 8 weeks, while Group B will only receive the breathing technique. Assessments will be done on menstrual cycle days, with follow-ups at weeks 4 and 8 using specific scales. Data will be analyzed using SPSS version 27.
Detailed description
This study will be a randomized clinical trial. Riphah International University QIE Campus in Lahore will serve as the site of data collecting and intervention services. Non-probability convenience sampling will be the method of sampling. The study's sample size will be 28 participants. Inclusion criteria for this study will be: women between ages 14-26 years, nulliparous women, with a score greater than 4 in WALIDD primary dysmenorrhea intensity scales, history of normal menstrual cycles that lasts 3-7 days and ranged from 21- 35 days, ability to perform exercises independently. Group A will be given kegel exercises as well as 4-7-8 breathing techniques for a total of 8 weeks with 4 sessions per week. Whereas, group B will be given the 4-7-8 breathing technique only. Initial assessment will be taken on the 3rd day of menstrual period. Follow-up assessment will be taken after week 4 post interventions and final assessment will be done after week 8 post intervention. WaLIDD primary dysmenorrhea intensity scale, Pain Self-Efficacy Questionnaire (PESQ), and Numeric Pain Rating Scale (NPRS) will be the data collecting instruments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kegel Exercise with4-7-8 Breathing technique group: | Experimental | Other: KegelExercise, Other: 4-7-8 breathing techniqueGroupAwill be given the intervention of kegel exercises as well as 4-7-8 breathing techniques for about 15 minutes per session for a total of 8 weeks with 4 sessions per week. To perform kegel exercises, tighten pelvic floor muscles like trying to hold in urine and stool. 4-7-8 breathing Technique can be performed by telling the participant to inhale to the count of 4. Hold their breath for 7 counts. To the count of 8, release air via their mouth. |
| 4-7-8 Breathing Technique group | Active comparator | Other: 4-7-8 breathing techniqueIn this group, we only perform the 4-7-8 Breathing Technique by telling the participant to inhale to the count of 4. Hold their breath for 7 counts. To the count of 8, release air via their mouth. |
Who may qualify
- Ages
- 14 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Nulliparous women
- Women with a score greater than 4 on WALIDD primary dysmenorrhea intensity scale
- Women having a history of normal menstrual cycles that lasts 3-7 days and range from 21- 35 days.
- Ability to perform exercises independently
Key exclusion criteria (5 listed)
- Women with very mild primary dysmenorrhea
- Women treated for ovarian cysts or other gynecological issues
- Women currently taking medication for dysmenorrhea
- History of any systemic illness
- A history of psychological conditions that could influence the perception of pain and functional activity.
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 |
|---|---|---|
| KegelExerciseKegel exercises (also called pelvic floor exercises)will be used to strengthen the pelvic floor muscles it will involve repeatedly contracting and relaxing the muscles that form part of the pelvic floor. | Other | Kegel Exercise with4-7-8 Breathing technique group: |
| 4-7-8 breathing techniqueThis can be performed in the following way: Participants taking part should locate a comfy spot to sit. Inhale to the count of 4. Hold their breath for 7 counts. To the count of 8, release air via their mouth. | Other | 4-7-8 Breathing Technique group, Kegel Exercise with4-7-8 Breathing technique group: |
Primary outcome
Numeric Pain Rating Scale
Time frame: up to 8 weeks
TheNPRSisa popular patient-reported response scale is the NPRS. The most widely used form of the NPRS is the ordinal 11-point version (0-no pain, 10-most extreme pain). A line or bar that is horizontal is the standard format. The NPRS is anchored by phrases that describe extremes of pain severity.
WALIDD Primary Dysmenorrhea Intensity Scale
Time frame: up to 8 weeks
WaLIDD stands for working ability, location, intensity, days of pain, dysmenorrhea. It is used to diagnose Primary dysmenorrhea as well its pain intensity and severity of symptoms. It is a new tool established and used in many researches and practices as a questionnaire to evaluate whether women are suffering from primary dysmenorrhea or not. The WaLIDD instrument is part of a confidential questionnaire that inquires about every factor to be examined, as well as details about age, menarche, menstrual cycle features, type and number of nonsurgical treatments used to manage dysmenorrhea, number of days of medical leave taken for dysmenorrhea.
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: up to 8 weeks
The Pain Self-Efficacy Questionnaire (PSEQ) is a valid instrument that is widely used to evaluate a person's comfort level with chronic pain management. Rhe PSEQ measures self-efficacy beliefs in pain management and how important it is to comprehend how pain affects both functional and emotional elements of life.
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 20 Nov 2024.
- Background: PubMed 32858887Abreu-Sanchez A, Parra-Fernandez ML, Onieva-Zafra MD, Ramos-Pichardo JD, Fernandez-Martinez E. Type of Dysmenorrhea, Menstrual Characteristics and Symptoms in Nursing Students in Southern Spain. Healthcare (Basel). 2020 Aug 26;8(3):302. doi: 10.3390/healthcare8030302.
- Background: PubMed 28944048Bernardi M, Lazzeri L, Perelli F, Reis FM, Petraglia F. Dysmenorrhea and related disorders. F1000Res. 2017 Sep 5;6:1645. doi: 10.12688/f1000research.11682.1. eCollection 2017.
- Background: PubMed 35305636Bakhsh H, Algenaimi E, Aldhuwayhi R, AboWadaan M. Prevalence of dysmenorrhea among reproductive age group in Saudi Women. BMC Womens Health. 2022 Mar 19;22(1):78. doi: 10.1186/s12905-022-01654-9.
- Background: PubMed 37374091Matsas A, Sachinidis A, Lamprinou M, Stamoula E, Christopoulos P. Vitamin Effects in Primary Dysmenorrhea. Life (Basel). 2023 Jun 1;13(6):1308. doi: 10.3390/life13061308.
- Individual participant dataSharing planned: No
Related trials for Primary Dysmenorrhea
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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.
Nirmal Zahid, MS* principal investigator
Riphah International University, Lahore, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KegelExercise and 4-7-8 breathing technique in people with Primary Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.
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 4 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 20 Nov 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 Pakistan. 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?
Numeric Pain Rating Scale (time frame: up to 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06339918, which also lists 4 linked publications.
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 20 Nov 2024.