Effect of Mobilization Training Given to Hysterectomy Operation on Bottom Functions and Pain

NCT06024044 | Completed DMC

• 1 other identifier: 2022/P428
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mobilization; Training Group

Keywords

Hysterectomy; Women; Post-Operational; Bottom Functions; Pain; Mobilization Training

Outcome Measures

Primary Outcomes (1)

• Pain evaluated using the Visual Analog Scale

  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).

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

Secondary Outcomes (1)

• Bottom functions evaluated using the Postoperative Follow-up Chart

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

Study Arms (2)

Control

NO INTERVENTION

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.

Mobilization Training

EXPERIMENTAL

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.

Behavioral: Mobilization Training

Interventions

Mobilization Training BEHAVIORAL

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.

Mobilization Training

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The women patients undergoing hysterectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University

Edirne, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Burcu Küçükkaya, Asst. Prof.

  Bartın University, Faculty of Health Sciences, Nursing Department, Division of Gynecology and Obstetrics Nursing, Bartın, Turkiye

  PRINCIPAL INVESTIGATOR

• Zeynep Kızılcık Özkan, Asst. Prof.

  Trakya University, Faculty of Health Sciences, Nursing Department, Division of Surgery Nursing, Edirne, Turkiye

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 5, 2023
• Study Start: May 12, 2022
• Primary Completion: May 14, 2022
• Study Completion: June 15, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

TU (1)