Clinical trial NCT06965595: The Effect of Different Physiotherapy Methods Applied After Gynecological Abdominal Surgery on Postoperative Symptoms
Official title: The Effect of Different Physiotherapy Methods Applied After Gynecological Abdominal Surgery on Postoperative Symptoms
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gynecologic Surgeries
Physical Therapy
Women Health
Keywords: Gynecological abdominal surgery
postoperative routine care
physiotherapy and rehabilitation
vagal stimulation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Nuh Naci Yazgan University
First posted: 2025-05-11
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Pain (VAS)
timeFrame: Day 1 and Day 2
measure: Pain threshold measurement
timeFrame: Baseline and Day 2
measure: Assessment of Autonomic Functions
timeFrame: Day 1 and Day 2
measure: Assessment of Autonomic Functions
timeFrame: Day 1 and Day 2
measure: Assessment of Autonomic Functions
timeFrame: Day 1 and Day 2
measure: Assessment of Autonomic Functions
timeFrame: Day 1 and Day 2
measure: Assessment of saturation (SpO₂)
timeFrame: Day 1 and Day 2
measure: Postoperative period
timeFrame: From enrollment to the end of treatment at 2 day
measure: The walking time
timeFrame: Postoperative
measure: First food intake
timeFrame: Postoperative
measure: Take a medicine
timeFrame: Day 1 and Day 2
measure: Umblikus
timeFrame: Day 1 and Day 2
measure: xiphoid - pubis distance
timeFrame: day 1 and day 2
measure: Postoperative period
timeFrame: Postoperative
Secondary outcomes:
measure: DETAILED STORIES OF THE PATIENTS
timeFrame: Before treatment
measure: Two minutes walk
timeFrame: Day 1 and Day 2
measure: Pelvic Floor
timeFrame: Day 1 and Day 2
measure: Pelvic Floor Distress Inventory-20 (PFDI-20)
timeFrame: Day1 and Day 2
measure: Quality of Recovery-40
timeFrame: Day 1 and Day 2
measure: Respiratory Function Test
timeFrame: Day 1 and Day 2
measure: Patient Satisfaction
timeFrame: Day 2
measure: Mini Mental Test
timeFrame: Before treatment
measure: Operation process
timeFrame: Baseline
Other outcomes:
Locations:
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