NCT05460962

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
Last Updated

December 9, 2022

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

July 14, 2022

Last Update Submit

December 7, 2022

Conditions

Keywords

Depression, Hysterectomy, Progressive muscle relaxation technique

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    8 weeks

Study Arms (2)

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

Other: Deep breathing excercisesOther: 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

Other: Deep breathing excercisesOther: Deep breathing exercises +and progressive muscle relaxation techniques

Interventions

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 excercise and progressive muscle relaxationDeep breathing excercises

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

Deep breathing excercise and progressive muscle relaxationDeep breathing excercises

Eligibility Criteria

Age35 Years - 55 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 ).

You may not qualify if:

  • Females with hormonal replacement therapy
  • Any history of cancer
  • Diagnosed patient of any psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Hafiza Neelam Muneeb, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2022

First Posted

July 15, 2022

Study Start

January 20, 2022

Primary Completion

July 15, 2022

Study Completion

July 15, 2022

Last Updated

December 9, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations