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临床试验/NCT06303245
NCT06303245招募中不适用

Combined Effects of Abdominal Binders and TENS on Post-operative Pain, Distress and Constipation in Puerperium Period After Cesarean Section

Riphah International University2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2023年2月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
28
试验地点
2
主要终点
o PAC-SYM Questionnaire

研究概览

简要总结

To determine the combined effects of abdominal binders and TENS on post-operative pain, distress and constipation in puerperium period after cesarean section

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 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Participants on early puerperium period having constipation and willing to participate.
  • Primigravida
  • Body mass index (BMI) less than 30 kg/m2

排除标准

  • Laxatives-induced patients
  • History of chronic constipation
  • Post cesarean abdominal suture infection.
  • People with chronic diseases, and who underwent non-routine or additional surgical procedures, such as hysterectomy, tubal ligation, and classical uterine incision.
  • Participants with inability to tolerate the binder.
  • Participants who show unwillingness to participate in the study

研究组 & 干预措施

ABDOMINAL BINDERS

Experimental

干预措施: ABDOMINAL BINDERS (Other)

TENS

Active Comparator

干预措施: TENS (Other)

结局指标

主要结局

o PAC-SYM Questionnaire

时间窗: 6th week

The PAC-SYM is a tool which is used to assess the severity of constipation. It range is from 0 and 48. Less value shows less severity of constipation. The patients were then asked to rate the severity of each symptom in a 5-point Likert scale (0-4; absent to very severe) during the past 2 weeks. The items were further categorized into 3 domains: abdominal symptoms (question 1-4), rectal symptoms (question 5-7), and stool symptoms (question 8-12). It is a reliable tool with value of 0.66 and validity with value of 0.75

o Numeric Pain rating Scale

时间窗: 6th week

Numeric pain rating scale is a subjective measure 11 point numerical scale which is used to measure pain. Is scoring range In this scale 0 shows no pain and 10 shows worst pain imaginable. It has good reliability of 0.79 and validity of 0.96.

o Symptom Distress scale

时间窗: 6th week

Symptom distress scale is a 13 item self-assessment scale with 13 symptoms like pain, fatigue, insomnia, lack of appetite, nausea, breathlessness, lack of concentration, lack of appetite and altered mood. It's scoring is done by using 5 point Likert scale where 1 shows least distress and 5 shows extreme distress. With a total score ranging from 13 to 65. It has a reliability of 0.821 and validity of 0.825.

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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