- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06965595
- Original Trial
The Effect of Different Physiotherapy Methods Applied After Gynecological Abdominal Surgery on Postoperative Symptoms
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.
Study Overview
Status
Conditions
Detailed Description
Gynecological pelvic surgeries refer to procedures performed in the pelvic region of women. These surgeries include procedures such as myomectomy, hysterectomy, and the removal of ovarian cysts. Surgical procedures can be performed through abdominal or vaginal routes.
Various complications may occur during or after surgical operations . In the postoperative period, complaints such as pain, decreased bowel motility (e.g., paralytic ileus) , gastrointestinal problems, nausea and vomiting, and pneumonia may occur . At the same time, the occurrence of these complaints may also lead to a decrease in the patient's level of mobility .
There are different treatment approaches for symptoms that occur in the postoperative period. In particular, pain is among the primary complaints of patients. This acute pain may lead to chronic pain and the analgesic agents used may cause side effects such as sedation, nausea, and ileus .
Physiotherapy and rehabilitation practices for gastrointestinal problems and pain in the postoperative period include applications such as breathing exercises, mobilization, and connective tissue massage .
In a study by Zia and colleagues on the effectiveness of early physiotherapy applications, cases who underwent abdominal hysterectomy were divided into two groups as control and experimental. The experimental group received a comprehensive physiotherapy rehabilitation plan including patient education, breathing exercises, early mobilization, connective tissue manipulation, and transcutaneous electrical nerve stimulation (TENS), while the control group only performed walking (ambulation). It was shown that participants in the experimental group had a faster time to first gas passage and a higher rate of defecation within the first 3 days compared to the control group. As a result of the study, it is stated that early postoperative intervention has the potential to accelerate the recovery process .
In another study, the effect of kinesio taping and breathing exercises on pain in cases undergoing gynecological abdominal surgery was examined. The researchers divided the participants into four groups: kinesio taping, breathing exercises, kinesio taping with breathing exercises, and control group, and conducted interventions for 3 days postoperatively. Time to gas passage and defecation times were evaluated, and kinesio taping was found to be the group with the best improvement in pain and the earliest gas passage time. The group that received kinesio taping and breathing exercises also showed shorter gas passage times. As a result, kinesio taping and kinesio taping with breathing exercises can be used as non-invasive methods in the postoperative period .
Recently, the vagal stimulation technique has come to the forefront among applications for pain relief . This method has also been used in individuals with complaints of constipation . Stimulation of the vagus nerve can be provided through invasive and non-invasive methods.
In a study conducted by Shi and colleagues in 2021, 42 patients with constipation-predominant irritable bowel syndrome were divided into two groups and received auricular vagal stimulation and sham vagal stimulation treatments. In this study, which examined constipation and abdominal pain, positive results such as increased bowel motility and reduced pain were obtained after 4 weeks .
In another study involving patients with chronic low back pain, 60 patients were divided into two groups to receive either conventional rehabilitation and home exercises or transcutaneous auricular vagal nerve stimulation and home exercises. At the end of the 3-week treatment program, intra-group evaluation results showed positive effects on mobility, functional status, depression, and sleep in all groups .
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kayseri, Turkey
- Nuh Naci Yazgan Unıversıty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Routine Care
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.
|
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.
|
|
Active Comparator: Rutin care + Physiotherapy
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.
|
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) |
|
Active Comparator: Routine care + vagal stimulation
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 vagal stimulation.
The stimulation will be applied to the cervical region at 10 Hz, 200 μs for 20 minutes, twice a day.
|
|
Active Comparator: Routine care + Physiotherapy + Vagal stimulation
In addition to routine care practices, this group will receive physiotherapy and rehabilitation, along with vagal stimulation.
|
In addition to routine care practices, this group will receive physiotherapy and rehabilitation, along with vagal stimulation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain (VAS)
Time Frame: Day 1 and Day 2
|
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
Time Frame: Baseline and Day 2
|
A digital algometer device will be used to determine the pain threshold.
|
Baseline and Day 2
|
|
Assessment of Autonomic Functions
Time Frame: Day 1 and Day 2
|
The recording will be made with an ECG device.R-R waves will be examined.
|
Day 1 and Day 2
|
|
Assessment of Autonomic Functions
Time Frame: Day 1 and Day 2
|
heart rate collected before and after the session.
|
Day 1 and Day 2
|
|
Assessment of Autonomic Functions
Time Frame: Day 1 and Day 2
|
Blood Pressure collected before and after the session.
|
Day 1 and Day 2
|
|
Assessment of Autonomic Functions
Time Frame: Day 1 and Day 2
|
respiratory rate collected before and after the session.
|
Day 1 and Day 2
|
|
Assessment of saturation (SpO₂)
Time Frame: Day 1 and Day 2
|
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
Time Frame: From enrollment to the end of treatment at 2 day
|
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
Time Frame: Postoperative
|
The time of first walking will be noted.
|
Postoperative
|
|
First food intake
Time Frame: Postoperative
|
The time of First food intake will be noted.
|
Postoperative
|
|
Take a medicine
Time Frame: Day 1 and Day 2
|
Analgesics and other medications taken will be noted.
|
Day 1 and Day 2
|
|
Umblikus
Time Frame: Day 1 and Day 2
|
Umbilicus circumference will be measured with a tape measure.
|
Day 1 and Day 2
|
|
xiphoid - pubis distance
Time Frame: day 1 and day 2
|
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
Time Frame: Postoperative
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DETAILED STORIES OF THE PATIENTS
Time Frame: Before treatment
|
Participants' age, height, weight, number and status of pregnancies (gravida, abortus, dilation & curettage, parity, number of living children, etc.), previous surgeries, medications used, comorbidities, chronic diseases, marital status, and current type of surgery will be assessed. Medical history, personal and family medical background, BMI, smoking habits, other lifestyle habits, and allergy status will also be evaluated. |
Before treatment
|
|
Two minutes walk
Time Frame: Day 1 and Day 2
|
The distance she can walk in two minutes will be recorded
|
Day 1 and Day 2
|
|
Pelvic Floor
Time Frame: Day 1 and Day 2
|
To assess the condition of the pelvic floor, researchers will evaluate it using the Visual Analog Scale (VAS).
This assessment will address whether the participant can feel the pelvic region, as well as the presence of pain, discomfort, or incontinence.
Min value is 0 .
It means no sense and max value is 10.
It means high score for question.
|
Day 1 and Day 2
|
|
Pelvic Floor Distress Inventory-20 (PFDI-20)
Time Frame: Day1 and Day 2
|
Pelvic floor symptoms will be evaluated using the Pelvic Floor Distress Inventory-20 (PFDI-20), which includes a separate subheading for these symptoms.The higher the score obtained from this questionnaire, the greater the degree of complaints about pelvic floor dysfunction.
|
Day1 and Day 2
|
|
Quality of Recovery-40
Time Frame: Day 1 and Day 2
|
It will be used to examine the recovery characteristics of the participants throughout the treatment process.Higher scores indicating higher levels of functioning or well-being.
|
Day 1 and Day 2
|
|
Respiratory Function Test
Time Frame: Day 1 and Day 2
|
It will be used to assess the patient's respiratory capacity.
|
Day 1 and Day 2
|
|
Patient Satisfaction
Time Frame: Day 2
|
Their satisfaction with the treatment will be evaluated.Minimum value is 0 and max value is 10.
Ten is a higher satisfaction.
Zero means no satisfaction.
|
Day 2
|
|
Mini Mental Test
Time Frame: Before treatment
|
It will be used to evaluate the cognitive status item included in the exclusion criteria.
|
Before treatment
|
|
Operation process
Time Frame: Baseline
|
Information regarding the surgery (duration and time) will be noted.
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2024/012/013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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