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临床试验/NCT06965595
NCT06965595Enrolling By Invitation不适用

The Effect of Different Physiotherapy Methods Applied After Gynecological Abdominal Surgery on Postoperative Symptoms

Hacettepe University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
56
试验地点
1
主要终点
Assessment of Autonomic Functions

研究概览

简要总结

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.

详细描述

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 .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Routine Care

Experimental

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.

干预措施: Routine care (Other)

Rutin care + Physiotherapy

Active Comparator

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.

干预措施: Routine care + Physiotherapy (Other)

Routine care + vagal stimulation

Active Comparator

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.

干预措施: Routine care + Vagal stimulation (Other)

Routine care + Physiotherapy + Vagal stimulation

Active Comparator

In addition to routine care practices, this group will receive physiotherapy and rehabilitation, along with vagal stimulation.

干预措施: Routine care + Physiotherapy + Vagal stimulation (Other)

结局指标

主要结局

Assessment of Autonomic Functions

时间窗: Day 1 and Day 2

The recording will be made with an ECG device.R-R waves will be examined.

Postoperative period

时间窗: Postoperative

The time when the first feeling of needing to urinate occurs and the time when the feeling of micturition occurs will be noted.

The walking time

时间窗: Postoperative

The time of first walking will be noted.

First food intake

时间窗: Postoperative

The time of First food intake will be noted.

Take a medicine

时间窗: Day 1 and Day 2

Analgesics and other medications taken will be noted.

Umblikus

时间窗: Day 1 and Day 2

Umbilicus circumference will be measured with a tape measure.

xiphoid - pubis distance

时间窗: 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.

Postoperative Pain (VAS)

时间窗: 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.

Pain threshold measurement

时间窗: Baseline and Day 2

A digital algometer device will be used to determine the pain threshold.

Assessment of saturation (SpO₂)

时间窗: 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.

Postoperative period

时间窗: 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.

次要结局

  • Mini Mental Test(Before treatment)
  • Operation process(Baseline)
  • 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)
  • Respiratory Function Test(Day 1 and Day 2)
  • Patient Satisfaction(Day 2)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Turkan Akbayrak

Prof. Dr.

Hacettepe University

研究点 (1)

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