Skip to main content
Clinical Trials/NCT05270447
NCT05270447
Completed
Not Applicable

Short-Term Effects of Connective Tissue Massage After Hysterectomy: A Randomized Controlled Study

Bozok University1 site in 1 country60 target enrollmentOctober 12, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Massage
Sponsor
Bozok University
Enrollment
60
Locations
1
Primary Endpoint
Pain score
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The aim of this study to investigate the effects of connective tissue massage (CTM) on pain, intestinal peristaltism and functionality after total laparoscopic (TLH) or abdominal hysterectomy (TAH). Patients who underwent TLH randomly group as TLH-CTM (n=15) and TLH control (n=16), and TAH randomly group as TAH-CTM (n=14) and TAH control (n=15). The postoperative daily monitoring sheet, Visual Analogue Scale (VAS), time of intestinal peristaltism employees to collect research data.

Detailed Description

Interventions In the control groups (TLH control and TAH control) only in-bed activities and walking recommendations will be given, and routine care (analgesics and wound care) applies. In addition, CTM applies in the CTM groups (TLH-CTM and TAH-CTM). Connective tissue manipulation: The patients are informed about CTM and its mechanism of action before starting the CTM application. CTM is performed by a trained physiotherapist as the patient was in a sitting position. All posterior connective tissue areas (sacral, lumbar, lower thoracic, scapular, inter-scapular, and cervical) are stimulated. Both short and long strokes will use during the manipulation. Each stroke will repeate three times, first on the right and then on the left of all desired zones. All sessions will terminated with long bilateral strokes to the iliac crest and subcostal regions. During manipulation, the pad of the middle finger will be in contact with the patient's skin. Application will take approximately 30-35 minutes depending on the area treated. CTM will apply twice: at postoperative 3rd hour and after 24 hours. Routine care and advising: In-bed activities will advice to the patients in both groups. In-bed activities are; rotation, sitting on the bedside, breathing exercises, range of motion exercises for upper and lower extremities. In addition, hourly walking activities are recommended after the anesthetic effect wore off. Vital signs (pulse rate, blood pressure, and respiratory rate) and body temperatures will evaluate regularly. The investigators, will determine the severity of severe pain with the VAS scale. According to the VAS scale, if the patient reports pain intensity between 7-10 out of 10, it means that she has severe pain. Patients will encourage for early ambulation. Initially, they walked 10-15 m inside their rooms and the amount of walking increased over time.

Registry
clinicaltrials.gov
Start Date
October 12, 2020
End Date
March 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Bozok University
Responsible Party
Principal Investigator
Principal Investigator

hanife dogan

Assistant Professor

Bozok University

Eligibility Criteria

Inclusion Criteria

  • volunteered to participate in the study,
  • those who underwent benign abdominal or laparoscopic hysterectomy,
  • who were stable at post-operative vital signs and those with no complications in the early postoperative period

Exclusion Criteria

  • they had oncological diseases,
  • chronic pain history, prolapse,
  • those who had previous abdominal surgery,
  • those with known psychological problems. For the CTM groups,
  • those with local infection (abscess etc.), open lesion/wound, scar tissue, edema, and hematoma in the lumbar region.

Outcomes

Primary Outcomes

Pain score

Time Frame: Change from baseline to postoperative 2 days

Visual analog scale was used to assess pain levels. The Visual analog scale, is a 10-cm horizontal line ranging from "No Pain-Score 0" to "Intolerable Pain-Score 10", where "0" indicates the absence of pain and "10" indicates the presence of very severe pain.Higher scores related with worse pain status.

Secondary Outcomes

  • The difficulty levels of the patients during functional activities(Two days)
  • the time of the first defecation after the surgery(Two days)
  • time of the first passage of flatus after the surgery(Two days)
  • Respiratory rates before and after interventions(Two days)
  • blood pressure before and after interventions(Two days)
  • Heart Rate before and after interventions(Two days)

Study Sites (1)

Loading locations...

Similar Trials