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临床试验/NCT06024044
NCT06024044已完成不适用

The Effect of Mobilization Training Given to Women Before the Hysterectomy Operation on Post-Operational Bottom Functions and Pain: A Randomized Controlled Study

Trakya University1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2022年5月12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
82
试验地点
1
主要终点
Pain evaluated using the Visual Analog Scale

研究概览

简要总结

Objectives: Research on the effect of mobilization training given to women before the hysterectomy operation on post-operational bottom functions and pain is a new and promising feld of research. However, high-level evidence on whether mobilization and mobilization training has an effect on bowel function and pain is insufficient. The present study addresses this research question.

Design: A two-arm randomized controlled trial was conducted in 82 women patients.

详细描述

This two-arm randomized controlled trial (RCT) was conducted in the women patients undergoing hysterectomy located in Edirne, between May 2022 and June 2023. During the intake, the women patients undergoing hysterectomy were informed about the goals and setup of the study and intervention, and assessed for eligibility by a brief standardized interview. The women patients undergoing hysterectomy who fulfilled our criteria received an information letter and informed consent form, as well as the baseline questionnaire. Those women patients undergoing hysterectomy that provided written informed consent for participation were included in the study. Assessments in both groups were performed before randomization (i.e., baseline) and directly after the intervention period.

Randomization: The women patients undergoing hysterectomy were randomly assigned to an education or control groups. A research assistant not actively involved in the design and data analysis of the study created a random distribution sequence and assigned participants to one of the two conditions (1:1 ratio).

Intervention:

Mobilization Training: A face-to-face "Patient Information Form" was applied to the training group in the first interview before the hysterectomy operation. The participants in the training group were given hysterectomy postoperative mobilization training by the researcher (B.K) using presentation and verbal information technique. A "Post-Operative Follow-up Chart" was given to the participants to fill in the 1st and 2nd postoperative days. The training group participants were followed up by the researcher on the 0th and 1st days after the operation in line with the mobilization training they received. The "Post-Operative Follow-up Chart" questioning the patients' mobilization times, distances, bowel functions and pain scores was filled in by the researcher in detail by face-to-face interview method. Mobilization time (minutes) and distance (meters) were evaluated by the patients and their relatives, and recorded on the chart, using the stopwatch and pedometer on the personal mobile phones of the patients.

Control Group: The women patients in the control group who underwent hysterectomy were informed that mobilization training would be performed after a postoperative 2-day waiting period. Meanwhile, no intervention was made except for any routine nursing care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Having hysterectomy surgery,
  • At least primary school graduate,
  • With good mental functions,
  • Not experiencing serious depression, anxiety and stress,
  • No serious postoperative complications,
  • No chronic pain,
  • No sensory problems (vision loss, auditory loss, etc.),
  • Women who volunteered to participate in the study.

排除标准

  • Diagnosed with depression, anxiety and stress disorder,
  • Diagnosed with chronic pain,
  • Women who did not volunteer to participate in the study

结局指标

主要结局

Pain evaluated using the Visual Analog Scale

时间窗: change from baseline implamentation patent and after 0 and 1 postoperative day of practice.

The intensity of pain is measured using the VAS, a valid and reliable tool for measuring experimental and clinical pain. The VAS is scored on a horizontal line of 10 cm (0=no pain and 10=worst possible pain).

次要结局

  • Bottom functions evaluated using the Postoperative Follow-up Chart(change from baseline implamentation patent and after 0 and 1 postoperative day of practice.)

研究者

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

Burcu KUCUKKAYA

Assist. Prof

Bartın Unıversity

研究点 (1)

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