The Effect of Different Physiotherapy Methods Applied After Gynecological Abdominal Surgery on Postoperative Symptoms
1 other identifier
interventional
56
1 country
1
Brief Summary
Gynecological pelvic surgeries include procedures such as myomectomy, hysterectomy, and removal of ovarian cysts performed in the pelvic region of women. In the postoperative period following these surgeries, symptoms such as pain, decreased bowel motility, gastrointestinal problems, nausea, and vomiting are commonly observed. Effective management of these symptoms is important to accelerate the recovery process and improve the quality of life of patients. This study is planned to evaluate the effectiveness of physiotherapy during the hospitalization period after gynecological abdominal surgery and to examine the effects of different approaches on postoperative symptoms. In our study, participants who undergo gynecological abdominal surgery and meet the inclusion and exclusion criteria will be divided into four groups for intervention. In addition to routine care, interventions including physiotherapy, vagal stimulation, and a combination of physiotherapy and vagal stimulation will be applied from the postoperative period until discharge. The effects of these interventions on pain, bowel function, autonomic functions, pelvic floor function, and walking will be examined.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2025
1 active site
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
First Submitted
Initial submission to the registry
March 28, 2025
CompletedFirst Posted
Study publicly available on registry
May 11, 2025
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedAugust 1, 2025
July 1, 2025
10 months
March 28, 2025
July 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (14)
Postoperative Pain (VAS)
Pain will be assessed before and after each session. Visual Analog Scale (VAS) will be used for this. Minimum value is 0 and max value is 10. Ten is a higher pain. Zero means no pain.
Day 1 and Day 2
Pain threshold measurement
A digital algometer device will be used to determine the pain threshold.
Baseline and Day 2
Assessment of Autonomic Functions
The recording will be made with an ECG device.R-R waves will be examined.
Day 1 and Day 2
Assessment of Autonomic Functions
heart rate collected before and after the session.
Day 1 and Day 2
Assessment of Autonomic Functions
Blood Pressure collected before and after the session.
Day 1 and Day 2
Assessment of Autonomic Functions
respiratory rate collected before and after the session.
Day 1 and Day 2
Assessment of saturation (SpO₂)
arterial oxygen saturation (SpO₂) levels of participants will be evaluated. The unit of measurement will be the percentage of oxygen saturation.
Day 1 and Day 2
Postoperative period
The time when the first feeling of needing to pass gas time and defecation occurs will be noted.
From enrollment to the end of treatment at 2 day
The walking time
The time of first walking will be noted.
Postoperative
First food intake
The time of First food intake will be noted.
Postoperative
Take a medicine
Analgesics and other medications taken will be noted.
Day 1 and Day 2
Umblikus
Umbilicus circumference will be measured with a tape measure.
Day 1 and Day 2
xiphoid - pubis distance
The distance between the xiphoid and pubis will be measured with a tape measure. It will be noted in cm.
day 1 and day 2
Postoperative period
The time when the first feeling of needing to urinate occurs and the time when the feeling of micturition occurs will be noted.
Postoperative
Secondary Outcomes (9)
DETAILED STORIES OF THE PATIENTS
Before treatment
Two minutes walk
Day 1 and Day 2
Pelvic Floor
Day 1 and Day 2
Pelvic Floor Distress Inventory-20 (PFDI-20)
Day1 and Day 2
Quality of Recovery-40
Day 1 and Day 2
- +4 more secondary outcomes
Study Arms (4)
Routine Care
EXPERIMENTALThis group will be the control group. Routine care practices carried out in the hospital (vital sign monitoring, administration of analgesics, anti-inflammatory and antibiotics when necessary, and mobilization starting from the 6th hour) will be applied and the data will be recorded.
Rutin care + Physiotherapy
ACTIVE COMPARATORIn addition to routine care practices, this group will receive physiotherapy and rehabilitation. During the postoperative period, the intervention will be applied twice a day.
Routine care + vagal stimulation
ACTIVE COMPARATORIn addition to routine care practices, this group will receive vagal stimulation. The stimulation will be applied to the cervical region at 10 Hz, 200 μs for 20 minutes, twice a day.
Routine care + Physiotherapy + Vagal stimulation
ACTIVE COMPARATORIn addition to routine care practices, this group will receive physiotherapy and rehabilitation, along with vagal stimulation.
Interventions
This group will be the control group. Routine care practices carried out in the hospital (vital sign monitoring, administration of analgesics, anti-inflammatory and antibiotics when necessary, and mobilization starting from the 6th hour) will be applied and the data will be recorded.
In addition to routine care practices, this group will receive physiotherapy and rehabilitation. During the postoperative period, the intervention will be applied twice a day. Posture training: Information about posture will be provided in different positions and training will be conducted. Breathing training (Diaphragmatic breathing, thoracic expansion exercises) In-bed mobilization (Lower and upper extremity exercises, foot-ankle exercises (dorsiflexion-plantar flexion / inversion-eversion), hip and knee flexion-extension exercises, cervical region joint range of motion and stretching exercises, upper extremity exercises (shoulder elevation, circumduction, elbow and wrist flexion-extension exercises), pelvic floor training and exercises) Out-of-bed mobilization (Sitting, standing, walking training after the 6th hour)
In addition to routine care practices, this group will receive vagal stimulation. The stimulation will be applied to the cervical region at 10 Hz, 200 μs for 20 minutes, twice a day.
In addition to routine care practices, this group will receive physiotherapy and rehabilitation, along with vagal stimulation.
Eligibility Criteria
You may qualify if:
- Being 18 years of age or older
- Having undergone surgery due to a gynecological condition
- Having undergone one of the following operations: hysterectomy, hysterectomy + oophorectomy, or hysterectomy + salpingo-oophorectomy
- Having undergone abdominal surgery
You may not qualify if:
- Development of any complications during or after surgery
- Presence of active malignancy
- Presence of severe organ failure
- Presence of uncontrolled cardiac or other systemic disorders
- Presence of neurological or cognitive diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hacettepe Universitylead
- Nuh Naci Yazgan Universitycollaborator
Study Sites (1)
Nuh Naci Yazgan Unıversıty
Kayseri, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
March 28, 2025
First Posted
May 11, 2025
Study Start
June 1, 2025
Primary Completion
April 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
August 1, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share