Maternal StressNCT06877325
Synergistic Effects of Traditional Chinese Medicine Practices and Pelvic Floor Muscle Training
A study testing PFMT, QGPFMT and Qigong in people with Maternal Stress, run by Guangxi College for Preschool Education at 1 site in China.
Trial summary
This study was conducted within a randomized controlled trial framework using a double-blind design. Participants were assigned to one of three intervention groups: the Pelvic Floor Muscle Training group (PFMT), the Pelvic Floor Muscle Training combined with the Qigong group (PFMTQG), and the Qigong Practice group… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Maternal Stress
- What is being tested?
- PFMT, QGPFMT and Qigong
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 10 Apr 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged 20-35 years.
- Within 12 months postpartum.
- Diagnosed with mild to moderate SUI.
- Physically capable of participating in mild to moderate exercise.
- Provided written informed consent.
Who cannot join
- Severe pelvic floor dysfunction.
- Systemic health conditions that contraindicate physical activity.
- Pregnant at the time of recruitment or planning pregnancy during the study
- Prior structured training in Qigong or PFMT.
- Ongoing physiotherapy for pelvic floor health.
- Participation in other urinary incontinence research.
- Inability to provide informed consent due to cognitive or language barriers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Synergistic Effects of Traditional Chinese Medicine Practices and Pelvic Floor Muscle Training on Postpartum Stress Urinary Incontinence
This study was conducted within a randomized controlled trial framework using a double-blind design. Participants were assigned to one of three intervention groups: the Pelvic Floor Muscle Training group (PFMT), the Pelvic Floor Muscle Training combined with the Qigong group (PFMTQG), and the Qigong Practice group (QG). Randomization was performed using a random number table. Professional trainers implemented the intervention programs. Researchers conducted a 12-week intervention study, with training sessions held thrice weekly. During the trial, participants agreed not to engage in other forms of physical exercise.
- Conditions
- Maternal Stress
- Being tested
- PFMT, QGPFMT, Qigong
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFMTBehavioural
The training is divided into three phases. The first phase is the foundation phase (Weeks 1-4), which primarily activates the pelvic floor muscles. Strengthening Phase (Weeks 5-8): Builds muscular endurance and control by increasing contraction duration. Consolidation Phase (Weeks 9-12): Enhances overall stability and strength through functional movements.
QGPFMTBehavioural
The training is divided into three phases: Foundation Phase (Weeks 1-4): Focuses on breath regulation and activation to promote energy flow and awaken the pelvic floor muscles. Strengthening Phase (Weeks 5-8): Combines core stability training to enhance muscle strength and flexibility. Consolidation Phase (Weeks 9-12): This phase strengthens core control while incorporating standing meditation and breathing exercises to harmonize body and mind, improving overall stability and endurance.
QigongBehavioural
The training is divided into three phases. The first phase (Weeks 1-4) focuses on breathing regulation and relaxation to enhance blood circulation and promote body recovery. Strengthening Phase (Weeks 5-8): Utilizes "Dao Yin" techniques to improve flexibility and stimulate energy flow. Consolidation Phase (Weeks 9-12): Emphasizes overall enhancement and core strengthening and incorporates extended deep breathing meditation to harmonize body and mind.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor muscle training | Experimental | Not described Receives: Behavioral: PFMT |
| Qigong with pelvic floor muscle training | Experimental | Not described Receives: Behavioral: QGPFMT |
| Qigong | Experimental | Not described Receives: Behavioral: Qigong |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incontinence Episode Frequency
Incontinence Episode Frequency (IEF) will be measured using a 72-hour bladder diary maintained by participants. Participants will be provided with a structured bladder diary template, which includes columns for recording each instance of urine leakage, the associated activity (e.g., coughing, sneezing, physical exertion), and the approximate volume of leakage (if subjectively estimable). The frequency of urine leakage episodes will be calculated by averaging the total number of incidents recorded over the three days at each assessment point. The 72-hour urinary incontinence episode values will represent the total number of leakage incidents observed across the three days and will be used to evaluate changes in IEF over time.
Measured: Month 3
1-hour Pad Test
Urine leakage will be objectively quantified using the 1-hour pad test, conducted at the same time points as the bladder diary assessments. Participants will be provided with pre-weighed absorbent pads and instructed to wear them for a continuous 1-hour period. During this time, participants will be asked to drink 500 ml of plain water over 15 minutes and perform normal activities, including simple walking for the next 30 minutes. In the last 15 minutes, participants will be instructed to perform the standard ICS provocation exercises in a private area. If a participant is found to have vaginal bleeding or excessive vaginal discharge, the test will be postponed and rescheduled for a later date. After the 1-hour period, participants will seal the pads in provided plastic bags and return them to the study site. Trained assessors will measure the weight difference between the pre- and post-use pads using a precision digital scale .
Measured: Month 3
Secondary outcomes (4)
Pelvic Floor Muscle Assessment
Pelvic floor muscle function will be assessed using a Peritron 9300V perineometer (Cardio Design Pty Ltd., Melbourne, Australia), a device widely used in clinical and research settings for measuring intravaginal pressure. To standardize measurements, participants will be asked to empty their bladder prior to the test, and the procedure will be thoroughly explained by the assessor to ensure understanding and comfort. Participants will undergo the assessment in a semi-recumbent position with knees bent and feet flat on the examination table. A sterile, single-use intravaginal pressure sensor will be lubricated with a water-based gel and inserted to ensure proper placement and participant comfort. During the assessment, participants will perform three maximal voluntary pelvic floor muscle contractions, each held for 5 seconds, with 10-second rest intervals between contractions to avoid fatigue. The highest pressure recorded from the three attempts will be used for analysis.
Measured: Month 3
Incontinence Impact Questionnaire-7
This tool is specifically designed to evaluate the effects of urinary incontinence on participants' daily lives, encompassing physical, emotional, and social domains. The IIQ-7 is a subset of the full Incontinence Impact Questionnaire, developed to measure the impact of urinary incontinence on women's quality of life in a concise format. It consists of seven items addressing the extent to which urinary leakage interferes with: physical activities, social interactions and emotional well-being. The total score ranges from 0 to 28, with higher scores indicating a greater negative impact on quality of life.
Measured: Month 3
Urinary Distress Inventory-6
The UDI-6 is a short-form version of the Urinary Distress Inventory and evaluates symptom-related distress associated with urinary incontinence. The six items target: urinary urgency, frequency, urinary leakage and bladder control issues.
Each item is scored on a 4-point Likert scale ranging from 0 = Not at all to 3 = Greatly. Total scores range from 0 to 24, with higher scores reflecting greater symptom distress.
Measured: Month 3
Psychological Well-being Assessment
Psychological well-being will be evaluated using the Perceived Stress Scale (PSS), a validated and widely used questionnaire designed to assess perceived stress levels over the past month. The PSS consists of 10 items, each reflecting an aspect of stress perception, such as feelings of unpredictability, uncontrollability, and being overwhelmed. Participants will rate their responses on a 5-point Likert scale, where 0 = never and 4 = very often, based on their experiences in the preceding month. Total scores range from 0 to 40, with higher scores indicating greater levels of perceived stress.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Oct 2022
- Primary completion1 Apr 2024
- Study completion10 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal StressStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangxi College for Preschool Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877325
- Sponsor's protocol ID
- GCPI2022
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- 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 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Effects of Traditional Chinese Medicine Practices and Pelvic Floor Muscle Training on Postpartum Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT06877325
- Acronym / sponsor ID
- GCPI2022
- Conditions
- Maternal Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Guangxi College for Preschool EducationUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 14 Mar 2025 (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.
This study was conducted within a randomized controlled trial framework using a double-blind design. Participants were assigned to one of three intervention groups: the Pelvic Floor Muscle Training group (PFMT), the Pelvic Floor Muscle Training combined with the Qigong group (PFMTQG), and the Qigong Practice group (QG). Randomization was performed using a random number table. Professional trainers implemented the intervention programs. Researchers conducted a 12-week intervention study, with training sessions held thrice weekly. During the trial, participants agreed not to engage in other forms of physical exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor muscle training | Experimental | Behavioral: PFMT |
| Qigong with pelvic floor muscle training | Experimental | Behavioral: QGPFMT |
| Qigong | Experimental | Behavioral: Qigong |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 20-35 years.
- Within 12 months postpartum.
- Diagnosed with mild to moderate SUI.
- Physically capable of participating in mild to moderate exercise.
- Provided written informed consent.
Key exclusion criteria (7 listed)
- Severe pelvic floor dysfunction.
- Systemic health conditions that contraindicate physical activity.
- Pregnant at the time of recruitment or planning pregnancy during the study
- Prior structured training in Qigong or PFMT.
- Ongoing physiotherapy for pelvic floor health.
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 |
|---|---|---|
| PFMTThe training is divided into three phases. The first phase is the foundation phase (Weeks 1-4), which primarily activates the pelvic floor muscles. Strengthening Phase (Weeks 5-8): Builds muscular endurance and control by increasing contraction duration. Consolidation Phase (Weeks 9-12): Enhances overall stability and strength through functional movements. | Behavioural | Pelvic floor muscle training |
| QGPFMTThe training is divided into three phases: Foundation Phase (Weeks 1-4): Focuses on breath regulation and activation to promote energy flow and awaken the pelvic floor muscles. Strengthening Phase (Weeks 5-8): Combines core stability training to enhance muscle strength and flexibility. Consolidation Phase (Weeks 9-12): This phase strengthens core control while incorporating standing meditation and breathing exercises to harmonize body and mind, improving overall stability and endurance. | Behavioural | Qigong with pelvic floor muscle training |
| QigongThe training is divided into three phases. The first phase (Weeks 1-4) focuses on breathing regulation and relaxation to enhance blood circulation and promote body recovery. Strengthening Phase (Weeks 5-8): Utilizes "Dao Yin" techniques to improve flexibility and stimulate energy flow. Consolidation Phase (Weeks 9-12): Emphasizes overall enhancement and core strengthening and incorporates extended deep breathing meditation to harmonize body and mind. | Behavioural | Qigong |
Primary outcome
Incontinence Episode Frequency
Time frame: Month 3
Incontinence Episode Frequency (IEF) will be measured using a 72-hour bladder diary maintained by participants. Participants will be provided with a structured bladder diary template, which includes columns for recording each instance of urine leakage, the associated activity (e.g., coughing, sneezing, physical exertion), and the approximate volume of leakage (if subjectively estimable). The frequency of urine leakage episodes will be calculated by averaging the total number of incidents recorded over the three days at each assessment point. The 72-hour urinary incontinence episode values will represent the total number of leakage incidents observed across the three days and will be used to evaluate changes in IEF over time.
1-hour Pad Test
Time frame: Month 3
Urine leakage will be objectively quantified using the 1-hour pad test, conducted at the same time points as the bladder diary assessments. Participants will be provided with pre-weighed absorbent pads and instructed to wear them for a continuous 1-hour period. During this time, participants will be asked to drink 500 ml of plain water over 15 minutes and perform normal activities, including simple walking for the next 30 minutes. In the last 15 minutes, participants will be instructed to perform the standard ICS provocation exercises in a private area. If a participant is found to have vaginal bleeding or excessive vaginal discharge, the test will be postponed and rescheduled for a later date. After the 1-hour period, participants will seal the pads in provided plastic bags and return them to the study site. Trained assessors will measure the weight difference between the pre- and post-use pads using a precision digital scale .
4 secondary outcomes
Pelvic Floor Muscle Assessment
Time frame: Month 3
Incontinence Impact Questionnaire-7
Time frame: Month 3
Urinary Distress Inventory-6
Time frame: Month 3
Psychological Well-being Assessment
Time frame: Month 3
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 14 Mar 2025.
- Individual participant dataSharing planned: No
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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 PFMT, QGPFMT and Qigong in people with Maternal Stress, run by Guangxi College for Preschool Education at 1 site in China.
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 7 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 14 Mar 2025. 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 China. 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?
Incontinence Episode Frequency (time frame: Month 3). The study lists 2 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 14 Mar 2025.