Primary Dysmenorrhea (PD)NCT07753408
Breathing Exercises Combined With Core Stabilization Exercises in Women With Primary Dysmenorrhea
A study testing Core Stabilization Exercises and Breathing Exercises Combined with Core Stabilization Exercises in people with Primary Dysmenorrhea (PD), run by University of Lahore at 1 site in Pakistan.
Trial summary
Primary dysmenorrhea is a common gynecological condition among women of reproductive age and is associated with pelvic pain, psychological distress, and reduced health-related quality of life. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Primary Dysmenorrhea (PD)
- What is being tested?
- Core Stabilization Exercises and Breathing Exercises Combined with Core Stabilization Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Oct 2025to 15 Apr 2026
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Female participants aged 18-25 years.
- Clinical diagnosis of primary dysmenorrhea confirmed through medical history or self-report.
- Baseline menstrual pain intensity of 4 or higher on the Visual Analog Scale (VAS).
- Willing to participate and provide written informed consent.
- Agree not to receive any additional treatment for dysmenorrhea during the study period.
Who cannot join
- Secondary dysmenorrhea caused by conditions such as endometriosis, adenomyosis, or uterine fibroids.
- Pregnancy or childbirth within the previous six months.
- Diagnosed pelvic floor disorders or chronic pelvic pain syndrome.
- Severe psychological disorders or chronic pain conditions that may interfere with outcome assessment.
- Premenstrual Dysphoric Disorder (PMDD).
- History of pelvic surgery within the previous 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Primary dysmenorrhea is a common gynecological condition among women of reproductive age and is associated with pelvic pain, psychological distress, and reduced health-related quality of life. Although core stabilization exercises and breathing exercises have individually demonstrated beneficial effects, evidence regarding their combined effectiveness remains limited.
This randomized controlled trial aims to compare the effects of core stabilization exercises alone with breathing exercises combined with core stabilization exercises in women with primary dysmenorrhea. Forty-eight women aged 18-25 years will be randomly allocated to either the control group (core stabilization exercises) or the experimental group (breathing exercises combined with core stabilization exercises). Both groups will participate in supervised exercise sessions three times per week for eight weeks.
Read more
Outcome measures will include menstrual pain intensity, psychological status, and health-related quality of life, assessed using the Visual Analog Scale (VAS), Depression Anxiety Stress Scales-21 (DASS-21), and 12-Item Short Form Health Survey (SF-12) at baseline and Week 8.
The study will determine whether adding breathing exercises to core stabilization exercises provides greater clinical benefits than core stabilization exercises alone.
Read the detailed description
Primary dysmenorrhea is one of the most common gynecological disorders affecting women of reproductive age and is characterized by recurrent menstrual pain that negatively affects physical, psychological, and social well-being. Exercise-based physiotherapy interventions have demonstrated beneficial effects in reducing pain and improving function; however, evidence regarding the combined use of breathing exercises and core stabilization exercises remains limited.
This randomized controlled trial is designed to compare the effectiveness of breathing exercises combined with core stabilization exercises versus core stabilization exercises alone in women with primary dysmenorrhea. A total of 48 eligible women aged 18-25 years will be randomly assigned to one of two groups.
The control group will receive core stabilization exercises, while the experimental group will receive breathing exercises combined with core stabilization exercises. Both groups will attend supervised exercise sessions three times per week for eight weeks.
Outcome measures will be assessed at baseline and Week 8. Menstrual pain intensity will be measured using the Visual Analog Scale (VAS), psychological status using the Depression Anxiety Stress Scales-21 (DASS-21), and health-related quality of life using the 12-Item Short Form Health Survey (SF-12).
Data will be analyzed using SPSS version 26. Independent-samples t-tests, paired-samples t-tests, and repeated-measures ANOVA will be used to compare outcomes within and between groups. The findings of this study will determine whether adding breathing exercises to core stabilization exercises provides greater improvements in pain intensity, psychological status, and quality of life than core stabilization exercises alone.
- Conditions
- Primary Dysmenorrhea (PD)
- Being tested
- Core Stabilization Exercises, Breathing Exercises Combined with Core Stabilization Exercises
- Keywords
- 1: primary dysmenorrhea, 2: Breathing exercises, 3: Core stabilization exercises, 4: Menstrual pain, 5: Health-related quality of life, 6: Psychological status, 7: Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Stabilization ExercisesBehavioural
Participants will perform a supervised core stabilization exercise program designed to improve trunk muscle strength, core stability, and pelvic stability. The intervention will be delivered three times per week for eight weeks, with each session lasting approximately 40 minutes.
Each session will begin with a 5-minute warm-up consisting of marching in place, torso rotations, side bends, cat-cow stretching, and hip circles.
The exercise program includes bicycle crunches (3 sets × 15 repetitions), abdominal curls (3 sets × 15 repetitions), standing trunk rotations (3 sets × 15 repetitions), side bends (3 sets × 15 repetitions), pelvic bridging (3 sets × 15 repetitions), and mountain climbers (3 sets × 15 repetitions). Rest intervals of 10-20 seconds will be provided between exercises.
Breathing Exercises Combined with Core Stabilization ExercisesBehavioural
Participants will receive supervised breathing exercises combined with the standard core stabilization exercise program. The intervention will be delivered three sessions per week for eight weeks, with each session lasting approximately 40 minutes.
The breathing exercise component will last approximately 8 minutes and will include the following techniques:
- Diaphragmatic Breathing: Participants will inhale deeply through the nose while allowing the abdomen to expand and then exhale slowly through the mouth.
- 4-7-8 Breathing: Participants will inhale through the nose for 4 seconds, hold their breath for 7 seconds, and exhale slowly through the mouth for 8 seconds.
- Alternate Nostril Breathing (Nadi Shodhana): Participants will perform alternate nostril breathing by inhaling and exhaling through alternate nostrils in a controlled sequence.
- Guided Relaxation with Slow Breathing: Participants will perform slow, controlled breathing while focusing on whole-body relaxation.
The breat
| Study group | Role | What they receive |
|---|---|---|
| Core Stabilization Exercises | Active comparator | Participants assigned to the control group will receive supervised core stabilization exercises three times per week for eight weeks. Each treatment session will last approximately 40 minutes. Receives: Behavioral: Core Stabilization Exercises |
| Breathing exercises combined with core stabilization exercises | Experimental | Participants assigned to the experimental group will receive breathing exercises combined with the same core stabilization exercise program as the control group. Treatment sessions will be conducted three times per week for eight weeks, with each session lasting approximately 40 minutes. Receives: Behavioral: Core Stabilization Exercises; Behavioral: Breathing Exercises Combined with Core Stabilization Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Menstrual Pain Intensity
Menstrual pain intensity assessed via the Visual Analog Scale (VAS). Scores range from 0 mm to 100 mm. Higher scores indicate greater pain intensity.
Measured: Baseline, Week 8
Secondary outcomes (5)
Change from Baseline in SF-12 Physical Component Summary Score
Physical health-related quality of life assessed via the SF-12 Physical Component Summary (PCS) score. Scores range from 0 to 100. Higher scores indicate better physical health.
Measured: Baseline, Week 8
Change from Baseline in SF-12 Mental Component Summary Score
Mental health-related quality of life assessed via the SF-12 Mental Component Summary (MCS) score. Scores range from 0 to 100. Higher scores indicate better mental health.
Measured: Baseline, Week 8
Change from Baseline in DASS-21 Depression Subscale Score
Depression symptoms assessed via the Depression subscale of the DASS-21. Scores range from 0 to 42. Higher scores indicate greater severity of depressive symptoms.
Measured: Baseline, Week 8
Change from Baseline in DASS-21 Anxiety Subscale Score
Anxiety symptoms assessed via the Anxiety subscale of the DASS-21. Scores range from 0 to 42. Higher scores indicate greater severity of anxiety symptoms.
Measured: Baseline, Week 8
Change from Baseline in DASS-21 Stress Subscale Score
Stress symptoms assessed via the Stress subscale of the DASS-21. Scores range from 0 to 42. Higher scores indicate greater severity of stress symptoms.
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start18 Oct 2025
- Primary completion20 Dec 2025
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Dysmenorrhea (PD)Studies of the same condition, open and under way.
- More trials run by University of LahoreThe 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
- Model description
- Parallel study model comparing two 8-week protocols (3 sessions/week, 40 mins/session). 1. Active Comparator (Control): Supervised core stabilization program. 2. Experimental Group: Breathing exercises combined with core stabilization. Routine structure: Warm-up (5 mins) includes marching, torso rotations, side bends, cat-cow, and hip circles to increase circulation. Breathing exercises (8 mins) include diaphragmatic, 4-7-8, guided slow, and alternate nostril breathing. Core stabilization (rest intervals 10-20s) targets transversus/rectus abdominis, internal/external obliques, multifidus, pelvic floor, gluteus medius/maximus, and diaphragm via bicycle crunches, abdominal curls, standing trunk rotations, side bends, pelvic bridging, and mountain climbers (each 3 sets x 15 reps) to improve pelvic stability and reduce menstrual discomfort.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753408
- Sponsor's protocol ID
- MSWH-PD-001
- Status last verified
- Nov 2025
- First submitted
- 24 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plans to share IPD due to institutional policy and participants confidentiality.
Publications
Mustain M, Shela M, Tri Y, Witriani W, Hussein M, editors. The Effect of Deep Breathing Relaxation Techniques on Reducing Dysmenorrhea Pain in Adolescent Girls at The Indah 43 Dormitory in Cemani Village. Proceeding of International Conference on Science, Health, And Technology; 2024. 17. Chodon L, Samuel J. Lalramzawni (2024) Core Stability Exercise on Low Back Ache, Back Endurance and Health Related Quality of Life in Primary Dysmenorrhea-A Single Group Experimental Study. Indian Journal of Science and Technology. 2024;17(24):2494-8. . Martire FG, Piccione E, Exacoustos C, Zupi E. Endometriosis and adolescence: the impact of dysmenorrhea. Journal of clinical medicine. 2023;12(17):5624. . Itani R, Soubra L, Karout S, Rahme D, Karout L, Khojah HM. Primary dysmenorrhea: pathophysiology, diagnosis, and treatment updates. Korean journal of family medicine. 2022;43(2):101.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathing Exercises Combined With Core Stabilization Exercises in Women With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT07753408
- Acronym / sponsor ID
- MSWH-PD-001
- Conditions
- Primary Dysmenorrhea (PD)
- Keywords
- 1: primary dysmenorrhea, 2: Breathing exercises, 3: Core stabilization exercises, 4: Menstrual pain, 5: Health-related quality of life, 6: Psychological status, 7: Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 18 Oct 2025 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 7 Aug 2026 (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.
Primary dysmenorrhea is a common gynecological condition among women of reproductive age and is associated with pelvic pain, psychological distress, and reduced health-related quality of life. Although core stabilization exercises and breathing exercises have individually demonstrated beneficial effects, evidence regarding their combined effectiveness remains limited.
This randomized controlled trial aims to compare the effects of core stabilization exercises alone with breathing exercises combined with core stabilization exercises in women with primary dysmenorrhea. Forty-eight women aged 18-25 years will be randomly allocated to either the control group (core stabilization exercises) or the experimental group (breathing exercises combined with core stabilization exercises). Both groups will participate in supervised exercise sessions three times per week for eight weeks.
Outcome measures will include menstrual pain intensity, psychological status, and health-related quality of life, assessed using the Visual Analog Scale (VAS), Depression Anxiety Stress Scales-21 (DASS-21), and 12-Item Short Form Health Survey (SF-12) at baseline and Week 8.
The study will determine whether adding breathing exercises to core stabilization exercises provides greater clinical benefits than core stabilization exercises alone.
Detailed description
Primary dysmenorrhea is one of the most common gynecological disorders affecting women of reproductive age and is characterized by recurrent menstrual pain that negatively affects physical, psychological, and social well-being. Exercise-based physiotherapy interventions have demonstrated beneficial effects in reducing pain and improving function; however, evidence regarding the combined use of breathing exercises and core stabilization exercises remains limited.
This randomized controlled trial is designed to compare the effectiveness of breathing exercises combined with core stabilization exercises versus core stabilization exercises alone in women with primary dysmenorrhea. A total of 48 eligible women aged 18-25 years will be randomly assigned to one of two groups.
The control group will receive core stabilization exercises, while the experimental group will receive breathing exercises combined with core stabilization exercises. Both groups will attend supervised exercise sessions three times per week for eight weeks.
Outcome measures will be assessed at baseline and Week 8. Menstrual pain intensity will be measured using the Visual Analog Scale (VAS), psychological status using the Depression Anxiety Stress Scales-21 (DASS-21), and health-related quality of life using the 12-Item Short Form Health Survey (SF-12).
Data will be analyzed using SPSS version 26. Independent-samples t-tests, paired-samples t-tests, and repeated-measures ANOVA will be used to compare outcomes within and between groups. The findings of this study will determine whether adding breathing exercises to core stabilization exercises provides greater improvements in pain intensity, psychological status, and quality of life than core stabilization exercises alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel study model comparing two 8-week protocols (3 sessions/week, 40 mins/session). 1. Active Comparator (Control): Supervised core stabilization program. 2. Experimental Group: Breathing exercises combined with core stabilization. Routine structure: Warm-up (5 mins) includes marching, torso rotations, side bends, cat-cow, and hip circles to increase circulation. Breathing exercises (8 mins) include diaphragmatic, 4-7-8, guided slow, and alternate nostril breathing. Core stabilization (rest intervals 10-20s) targets transversus/rectus abdominis, internal/external obliques, multifidus, pelvic floor, gluteus medius/maximus, and diaphragm via bicycle crunches, abdominal curls, standing trunk rotations, side bends, pelvic bridging, and mountain climbers (each 3 sets x 15 reps) to improve pelvic stability and reduce menstrual discomfort.
| Arm | Type | Receives |
|---|---|---|
| Core Stabilization Exercises | Active comparator | Behavioral: Core Stabilization ExercisesParticipants assigned to the control group will receive supervised core stabilization exercises three times per week for eight weeks. Each treatment session will last approximately 40 minutes. |
| Breathing exercises combined with core stabilization exercises | Experimental | Behavioral: Core Stabilization Exercises, Behavioral: Breathing Exercises Combined with Core Stabilization ExercisesParticipants assigned to the experimental group will receive breathing exercises combined with the same core stabilization exercise program as the control group. Treatment sessions will be conducted three times per week for eight weeks, with each session lasting approximately 40 minutes. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female participants aged 18-25 years.
- Clinical diagnosis of primary dysmenorrhea confirmed through medical history or self-report.
- Baseline menstrual pain intensity of 4 or higher on the Visual Analog Scale (VAS).
- Willing to participate and provide written informed consent.
- Agree not to receive any additional treatment for dysmenorrhea during the study period.
Key exclusion criteria (6 listed)
- Secondary dysmenorrhea caused by conditions such as endometriosis, adenomyosis, or uterine fibroids.
- Pregnancy or childbirth within the previous six months.
- Diagnosed pelvic floor disorders or chronic pelvic pain syndrome.
- Severe psychological disorders or chronic pain conditions that may interfere with outcome assessment.
- Premenstrual Dysphoric Disorder (PMDD).
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 |
|---|---|---|
| Core Stabilization ExercisesParticipants will perform a supervised core stabilization exercise program designed to improve trunk muscle strength, core stability, and pelvic stability. The intervention will be delivered three times per week for eight weeks, with each session lasting approximately 40 minutes. Each session will begin with a 5-minute warm-up consisting of marching in place, torso rotations, side bends, cat-cow stretching, and hip circles. The exercise program includes bicycle crunches (3 sets × 15 repetitions), abdominal curls (3 sets × 15 repetitions), standing trunk rotations (3 sets × 15 repetitions), side bends (3 sets × 15 repetitions), pelvic bridging (3 sets × 15 repetitions), and mountain climbers (3 sets × 15 repetitions). Rest intervals of 10-20 seconds will be provided between exercises. | Behavioural | Breathing exercises combined with core stabilization exercises, Core Stabilization Exercises |
| Breathing Exercises Combined with Core Stabilization ExercisesParticipants will receive supervised breathing exercises combined with the standard core stabilization exercise program. The intervention will be delivered three sessions per week for eight weeks, with each session lasting approximately 40 minutes. The breathing exercise component will last approximately 8 minutes and will include the following techniques: * Diaphragmatic Breathing: Participants will inhale deeply through the nose while allowing the abdomen to expand and then exhale slowly through the mouth. * 4-7-8 Breathing: Participants will inhale through the nose for 4 seconds, hold their breath for 7 seconds, and exhale slowly through the mouth for 8 seconds. * Alternate Nostril Breathing (Nadi Shodhana): Participants will perform alternate nostril breathing by inhaling and exhaling through alternate nostrils in a controlled sequence. * Guided Relaxation with Slow Breathing: Participants will perform slow, controlled breathing while focusing on whole-body relaxation. The breat | Behavioural | Breathing exercises combined with core stabilization exercises |
Primary outcome
Change from Baseline in Menstrual Pain Intensity
Time frame: Baseline, Week 8
Menstrual pain intensity assessed via the Visual Analog Scale (VAS). Scores range from 0 mm to 100 mm. Higher scores indicate greater pain intensity.
5 secondary outcomes
Change from Baseline in SF-12 Physical Component Summary Score
Time frame: Baseline, Week 8
Change from Baseline in SF-12 Mental Component Summary Score
Time frame: Baseline, Week 8
Change from Baseline in DASS-21 Depression Subscale Score
Time frame: Baseline, Week 8
Change from Baseline in DASS-21 Anxiety Subscale Score
Time frame: Baseline, Week 8
Change from Baseline in DASS-21 Stress Subscale Score
Time frame: Baseline, Week 8
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 7 Aug 2026.
- Results publicationMustain M, Shela M, Tri Y, Witriani W, Hussein M, editors. The Effect of Deep Breathing Relaxation Techniques on Reducing Dysmenorrhea Pain in Adolescent Girls at The Indah 43 Dormitory in Cemani Village. Proceeding of International Conference on Science, Health, And Technology; 2024. 17. Chodon L, Samuel J. Lalramzawni (2024) Core Stability Exercise on Low Back Ache, Back Endurance and Health Related Quality of Life in Primary Dysmenorrhea-A Single Group Experimental Study. Indian Journal of Science and Technology. 2024;17(24):2494-8. . Martire FG, Piccione E, Exacoustos C, Zupi E. Endometriosis and adolescence: the impact of dysmenorrhea. Journal of clinical medicine. 2023;12(17):5624. . Itani R, Soubra L, Karout S, Rahme D, Karout L, Khojah HM. Primary dysmenorrhea: pathophysiology, diagnosis, and treatment updates. Korean journal of family medicine. 2022;43(2):101.
- Individual participant dataSharing planned: No. no plans to share IPD due to institutional policy and participants confidentiality.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Stabilization Exercises and Breathing Exercises Combined with Core Stabilization Exercises in people with Primary Dysmenorrhea (PD), run by University of Lahore 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 5 inclusion and 6 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 7 Aug 2026. 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?
Change from Baseline in Menstrual Pain Intensity (time frame: Baseline, Week 8). 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 NCT07753408, which also lists 1 linked publication.
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 7 Aug 2026.