Primary DysmenorrheaNCT04475874
Stretching Exercises on Symptoms of Primary Dysmenorrhea
A study testing supervised stretching exercises and non-supervised active stretching home program in people with Primary Dysmenorrhea, run by Cairo University at 1 site in Saudi Arabia.
Trial summary
The purpose of this study was to assess the effect of active stretching exercises on reducing pain and the quality of life during menstrual cycle in young adult females. Read more about this study
- Who is it for?
- Ages 18 to 23 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- supervised stretching exercises and non-supervised active stretching home program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Feb 2019to 12 Feb 2020
- 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 23 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI of 20-29.9 kg/m2,
- regular menstrual cycle
- length 28-30 day
- cycle bleed from 3 to 7 days,
Who cannot join
- contraindication to stretching exercise
- taking any hormonal medications:
- smoker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Active Stretching Exercises on Symptoms of Primary Dysmenorrhea
The purpose of this study was to assess the effect of active stretching exercises on reducing pain and the quality of life during menstrual cycle in young adult females.
Read the detailed description
Thirty females with primary dysmenorrhea, aging between 18 to 23 years with BMI of 20-29.9 kg/m2, have a regular menstrual cycle length 28-30 day and cycle bleed from 3 to 7 days, were randomly assigned into three equal groups; two interventions groups (supervised and non-supervised active stretching exercise program) and one control group. The intervention group A practiced a 30 to 45-minute supervised active stretching program three times a week for four weeks, while the other intervention group B practiced non-supervised active stretching home program and the control group C . Visual Analog Scale (VAS) was used to measure pain intensity, and Verbal Multidimensional System (VMS) for measuring menstruation characteristics and the effect of pain on quality of life, before (pre) as well as after (post) 4 weeks at the end of the study .
- Conditions
- Primary Dysmenorrhea
- Being tested
- supervised stretching exercises, non-supervised active stretching home program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supervised stretching exercisesOther
Also called home program stretching exercises
30 to 45-minute supervised active stretching program by a trained physical therapist, three times a week for four weeks starting with a warmup of 5 minutes on a stationary bicycle, half jumping jacks and torso rotations
non-supervised active stretching home programOther
Also called home program of stretching exercises
non supervised 30 to 45-minute supervised active stretching program three times a week for four weeks starting with a warmup of 5 minutes on a stationary bicycle, half jumping jacks and torso rotations
| Study group | Role | What they receive |
|---|---|---|
| supervised stretching exercises :group A | Active comparator | The intervention group A practiced a 30 to 45-minute supervised active stretching program three times a week for four weeks Receives: Other: supervised stretching exercises |
| non-supervised active stretching home program: group B | Active comparator | practiced non-supervised active stretching home program Receives: Other: non-supervised active stretching home program |
| Standard of care: group c | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Visual Analog Scale measures pain intensity it is a unidimensional measure of pain intensity The classification of VAS was done according to pain scores (mild: 1-3 Moderate: 4-7 Severe: 8-10)
Measured: Change from Baseline at pain intensity 4 weeks after
Secondary outcomes (1)
Verbal Multidimensional System(VMS)
Verbal Multidimensional System which is a grading system from zero to three and used to evaluate menstruation characteristics including the working ability, the systemic symptoms and analgesia requirement in order to decrease pain with dysmenorrhea
Measured: Change from Baseline amenstruation characteristics 4 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start10 Feb 2019
- Primary completion12 Jan 2020
- Study completion12 Feb 2020
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.
- More trials run by Cairo 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Nourah Bint Abdulrahman University
- Responsible party
- Principal investigator, ZIZI MOHAMMED IBRAHIM ALI, Princess Nourah Bint Abdulrahman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475874
- Sponsor's protocol ID
- DPTPNU
- Status last verified
- Jul 2020
- First submitted
- 12 Jul 2020
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Active Stretching Exercises on Symptoms of Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT04475874
- Acronym / sponsor ID
- DPTPNU
- Conditions
- Primary Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Princess Nourah Bint Abdulrahman University
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- 12 Jan 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 17 Jul 2020 (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.
The purpose of this study was to assess the effect of active stretching exercises on reducing pain and the quality of life during menstrual cycle in young adult females.
Detailed description
Thirty females with primary dysmenorrhea, aging between 18 to 23 years with BMI of 20-29.9 kg/m2, have a regular menstrual cycle length 28-30 day and cycle bleed from 3 to 7 days, were randomly assigned into three equal groups; two interventions groups (supervised and non-supervised active stretching exercise program) and one control group. The intervention group A practiced a 30 to 45-minute supervised active stretching program three times a week for four weeks, while the other intervention group B practiced non-supervised active stretching home program and the control group C . Visual Analog Scale (VAS) was used to measure pain intensity, and Verbal Multidimensional System (VMS) for measuring menstruation characteristics and the effect of pain on quality of life, before (pre) as well as after (post) 4 weeks at the end of the study .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| supervised stretching exercises :group A | Active comparator | Other: supervised stretching exercisesThe intervention group A practiced a 30 to 45-minute supervised active stretching program three times a week for four weeks |
| non-supervised active stretching home program: group B | Active comparator | Other: non-supervised active stretching home programpracticed non-supervised active stretching home program |
| Standard of care: group c | No intervention | –control group |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI of 20-29.9 kg/m2,
- regular menstrual cycle
- length 28-30 day
- cycle bleed from 3 to 7 days,
Key exclusion criteria (3 listed)
- contraindication to stretching exercise
- taking any hormonal medications:
- smoker
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 |
|---|---|---|
| supervised stretching exercisesAlso: home program stretching exercises30 to 45-minute supervised active stretching program by a trained physical therapist, three times a week for four weeks starting with a warmup of 5 minutes on a stationary bicycle, half jumping jacks and torso rotations | Other | supervised stretching exercises :group A |
| non-supervised active stretching home programAlso: home program of stretching exercisesnon supervised 30 to 45-minute supervised active stretching program three times a week for four weeks starting with a warmup of 5 minutes on a stationary bicycle, half jumping jacks and torso rotations | Other | non-supervised active stretching home program: group B |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Change from Baseline at pain intensity 4 weeks after
Visual Analog Scale measures pain intensity it is a unidimensional measure of pain intensity The classification of VAS was done according to pain scores (mild: 1-3 Moderate: 4-7 Severe: 8-10)
1 secondary outcome
Verbal Multidimensional System(VMS)
Time frame: Change from Baseline amenstruation characteristics 4 weeks after
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 17 Jul 2020.
- 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.
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 supervised stretching exercises and non-supervised active stretching home program in people with Primary Dysmenorrhea, run by Cairo University at 1 site in Saudi Arabia.
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 3 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 17 Jul 2020. 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 Saudi Arabia. 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?
Visual Analog Scale (VAS) (time frame: Change from Baseline at pain intensity 4 weeks after). 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 17 Jul 2020; AzTrials last refreshed its copy on 6 Nov 2026.