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临床试验/NCT04686032
NCT04686032已完成不适用

Effect of Early Physical Therapy Interventions on Post-operative Recovery and Complications Following Abdominal Hysterectomy

Riphah International University2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
Numeric pain rating scale (NPRS)

研究概览

简要总结

Variety of physical therapy treatments have been used after open abdominal surgery to improve cardiopulmonary and physical function as well as to reduce the incidence of postoperative pulmonary complications. This study intends to determine the effect of early physical therapy interventions on post-operative recovery profile, post-operative ileus and incisional pain following abdominal hysterectomy.

详细描述

This study is randomized controlled trial which will be conducted at in-patient gynecology department of Pakistan Railway hospital. This study would include total of 42 participants divided into two groups with 21 participants in each group calculated through OpenEpi (CI=95%Power=80%). Individuals will be screened according to inclusion and exclusion criteria and allocated randomly into two groups through sealed envelope method. Experimental group will receive early physical therapy interventions including patient education, ambulation, in-bed exercises, deep breathing exercises, connective tissue manipulation and TENS during the first 3 post-operative days following abdominal hysterectomy. While the control group will receive patient education and early ambulation during the first 3 post-operative days following abdominal hysterectomy.

Post-operative recovery will be assessed on 3rd post-operative day. Intensity of pain will be measured on baseline and 3rd post-operative day. The effect of intervention on post-operative ileus will be measured by monitoring each participant's time to tolerance of oral diet, first passage of stool and flatus

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)

盲法说明

This study will be single blinded randomized control trail, participants will be unaware of treatment groups, they will be randomly allocated through sealed envelope method.

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • open abdominal hysterectomy
  • Patient awake and responsive, stable blood pressure, stable heart rate, no dyspnea at rest and pain score < 8 on visual analogue scale on first post-operative day.
  • No limitation on physical activities due to any medical problem or restriction by the physician.

排除标准

  • Other hysterectomy procedures i.e. laparoscopic or vaginal hysterectomy.
  • Females with diabetes or cancer of metastatic nature.
  • Neurological or cognitive deficit.
  • Ongoing respiratory problem prior to initiation of physical therapy session.
  • Medical recommendation not to participate in early active rehabilitation

结局指标

主要结局

Numeric pain rating scale (NPRS)

时间窗: Post 3rd day

Numeric pain rating scale (NPRS) will be used for evaluating intensity of the incisional pain. Its scores range from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.

Postoperative recovery profile questionnaire

时间窗: Post 3rd day

For hospitalized patients a 17-item version of the PRP will be used (excluding the items "Re-establishing everyday life" and "Sexual activity"). The global score ranges from 0 to 17.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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