Post-Hysterectomy Vaginal Vault ProlapseNCT05460962
Effects of Deep Breathing Excercises With and Without PMR on Depression & QOL in Females With Hystrectomy
A study testing Deep breathing excercises and Deep breathing exercises +and progressive muscle relaxation techniques in people with Post-Hysterectomy Vaginal Vault Prolapse, run by Riphah International University at 1 site in Pakistan.
Trial summary
To find out the Effects of deep breathing exercises with and without Progressive Muscle Relaxation Technique on depression and Quality of life in females with hysterotomy Read more about this study
- Who is it for?
- Ages 35 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-Hysterectomy Vaginal Vault Prolapse
- What is being tested?
- Deep breathing excercises and Deep breathing exercises +and progressive muscle relaxation techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jan 2022to 15 Jul 2022
- 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 35 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 35-55
- Females gone through all types of hysterotomy
- Hysterotomy done due to heavy menstrual bleeding, fibroids, pelvic pain, endometriosis and MAP ( Morbidly adherent placenta ).
Who cannot join
- Females with hormonal replacement therapy
- Any history of cancer
- Diagnosed patient of any psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Deep Breathing Excercises With and Without Progressive Muscle Relaxation Technique on Depression and Quality of Life in Females With Hystrectomy
To find out the Effects of deep breathing exercises with and without Progressive Muscle Relaxation Technique on depression and Quality of life in females with hysterotomy
- Conditions
- Post-Hysterectomy Vaginal Vault Prolapse
- Being tested
- Deep breathing excercises, Deep breathing exercises +and progressive muscle relaxation techniques
- Keywords
- Depression, Hysterectomy, Progressive muscle relaxation technique
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep breathing excercisesOther
Deep breathing, which is also known as diaphragmatic breathing, is a technique that is based on the notion that mind and body integration produces relaxation technique requires participants to contract the diaphragm, slowly inhaling and exhaling. Deep breathing appears to amplify blood oxygen levels, massages the inner organs located in or close to the abdomen, and possibly stimulates the vagus nerve
Deep breathing exercises +and progressive muscle relaxation techniquesOther
Begin with a deep breathing exercise. Inhale deeply through your nose, feeling your abdomen rise as you fill your body with air. Then slowly exhale out the mouth, the navel pulling in toward the spine as you expel the stale air out. Repeat 3-5 cycles
| Study group | Role | What they receive |
|---|---|---|
| Deep breathing excercises | Experimental | is a technique that is based on the notion that mind and body integration produces relaxation technique requires participants to contract the diaphragm, slowly inhaling and exhaling. Deep breathing appears to amplify blood oxygen levels, massages the inner organs located in or close to the abdomen, and possibly stimulates the vagus nerve Receives: Other: Deep breathing excercises; Other: Deep breathing exercises +and progressive muscle relaxation techniques |
| Deep breathing excercise and progressive muscle relaxation | Experimental | Begin with a deep breathing exercise. Inhale deeply through your nose, feeling your abdomen rise as you fill your body with air. Then slowly exhale out the mouth, the navel pulling in toward the spine as you expel the stale air out. Repeat 3-5 cycles Receives: Other: Deep breathing excercises; Other: Deep breathing exercises +and progressive muscle relaxation techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory
The Beck Depression Inventory (BDI) created by Aaron T. Beck, is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. Its development marked a shift among mental health professionals, who had until then, viewed depression from a psychodynamic perspective, instead of it being rooted in the patient's own thoughts.
Measured: 8 weeks
WHOQOL-BREFF
Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale (16, 17). The physical health domain includes items on mobility, daily activities, functional capacity, energy, pain, and sleep.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start20 Jan 2022
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Hysterectomy Vaginal Vault ProlapseStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafiza Neelam Muneeb, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460962
- Sponsor's protocol ID
- REC/RCR&AHS/22/0515
- Status last verified
- Dec 2022
- First submitted
- 14 Jul 2022
- Last updated
- 9 Dec 2022
- 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 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Deep Breathing Excercises With and Without Progressive Muscle Relaxation Technique on Depression and Quality of Life in Females With Hystrectomy
- ClinicalTrials.gov ID
- NCT05460962
- Acronym / sponsor ID
- REC/RCR&AHS/22/0515
- Conditions
- Post-Hysterectomy Vaginal Vault Prolapse
- Keywords
- Depression, Hysterectomy, Progressive muscle relaxation technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 15 Jul 2022 (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.
To find out the Effects of deep breathing exercises with and without Progressive Muscle Relaxation Technique on depression and Quality of life in females with hysterotomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep breathing excercises | Experimental | Other: Deep breathing excercises, Other: Deep breathing exercises +and progressive muscle relaxation techniquesis a technique that is based on the notion that mind and body integration produces relaxation technique requires participants to contract the diaphragm, slowly inhaling and exhaling. Deep breathing appears to amplify blood oxygen levels, massages the inner organs located in or close to the abdomen, and possibly stimulates the vagus nerve |
| Deep breathing excercise and progressive muscle relaxation | Experimental | Other: Deep breathing excercises, Other: Deep breathing exercises +and progressive muscle relaxation techniquesBegin with a deep breathing exercise. Inhale deeply through your nose, feeling your abdomen rise as you fill your body with air. Then slowly exhale out the mouth, the navel pulling in toward the spine as you expel the stale air out. Repeat 3-5 cycles |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 35-55
- Females gone through all types of hysterotomy
- Hysterotomy done due to heavy menstrual bleeding, fibroids, pelvic pain, endometriosis and MAP ( Morbidly adherent placenta ).
Key exclusion criteria (3 listed)
- Females with hormonal replacement therapy
- Any history of cancer
- Diagnosed patient of any psychiatric illness
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 |
|---|---|---|
| Deep breathing excercisesDeep breathing, which is also known as diaphragmatic breathing, is a technique that is based on the notion that mind and body integration produces relaxation technique requires participants to contract the diaphragm, slowly inhaling and exhaling. Deep breathing appears to amplify blood oxygen levels, massages the inner organs located in or close to the abdomen, and possibly stimulates the vagus nerve | Other | Deep breathing excercise and progressive muscle relaxation, Deep breathing excercises |
| Deep breathing exercises +and progressive muscle relaxation techniquesBegin with a deep breathing exercise. Inhale deeply through your nose, feeling your abdomen rise as you fill your body with air. Then slowly exhale out the mouth, the navel pulling in toward the spine as you expel the stale air out. Repeat 3-5 cycles | Other | Deep breathing excercise and progressive muscle relaxation, Deep breathing excercises |
Primary outcome
Beck Depression Inventory
Time frame: 8 weeks
The Beck Depression Inventory (BDI) created by Aaron T. Beck, is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. Its development marked a shift among mental health professionals, who had until then, viewed depression from a psychodynamic perspective, instead of it being rooted in the patient's own thoughts.
WHOQOL-BREFF
Time frame: 8 weeks
Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale (16, 17). The physical health domain includes items on mobility, daily activities, functional capacity, energy, pain, and sleep.
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 9 Dec 2022.
- Individual participant dataSharing planned: No
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Visceral Prolapse
Recruiting
Post-Hysterectomy Vaginal Length: Horizontal vs. Vertical Closure
Prolapse, Vaginal, Vaginal Vault Prolapse
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.
Hafiza Neelam Muneeb, MS principal investigator
Riphah International 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 Deep breathing excercises and Deep breathing exercises +and progressive muscle relaxation techniques in people with Post-Hysterectomy Vaginal Vault Prolapse, 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 3 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 9 Dec 2022. 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?
Beck Depression Inventory (time frame: 8 weeks). 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 9 Dec 2022.