Short-Term Effects of Connective Tissue Massage After Hysterectomy

Sponsor
Bozok University (Other)
Overall Status
Completed
CT.gov ID
NCT05270447
Collaborator
(none)
60
1
4
4.6
13

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Massage and patient education
  • Behavioral: Routine care and advising
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Controlled StudyRandomized Controlled Study
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Short-Term Effects of Connective Tissue Massage After Hysterectomy: A Randomized Controlled Study
Actual Study Start Date :
Oct 12, 2020
Actual Primary Completion Date :
Jan 10, 2021
Actual Study Completion Date :
Mar 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Total laparoscopic hysterectomy (TLH) Connetive tissue massage group

Connective tissue massage+ routine care+ advising

Other: Massage and patient education
Connective tissue manipulation: The patients were informed about CTM and its mechanism of action before starting the CTM application. CTM was performed by a trained physiotherapist as the patient was in a sitting position. Routine care and advising: In-bed activities were taught and recommended to the patients in both groups. In-bed activities; rotation, sitting on the bedside, breathing exercises, range of motion exercises for upper and lower extremities. In addition, hourly walking activities were recommended after the anesthetic effect wore off.

Behavioral: Routine care and advising
Routine care and advising: In-bed activities were taught and recommended to the patients in both groups. In-bed activities; rotation, sitting on the bedside, breathing exercises, range of motion exercises for upper and lower extremities. In addition, hourly walking activities were recommended after the anesthetic effect wore off.

Other: Total laparoscopic hysterectomy (TLH) control group

routine care+ advising

Behavioral: Routine care and advising
Routine care and advising: In-bed activities were taught and recommended to the patients in both groups. In-bed activities; rotation, sitting on the bedside, breathing exercises, range of motion exercises for upper and lower extremities. In addition, hourly walking activities were recommended after the anesthetic effect wore off.

Experimental: Total abdominal hysterectomy (TAH) Connetive tissue massage group

Connective tissue massage+ routine care+ advising

Other: Massage and patient education
Connective tissue manipulation: The patients were informed about CTM and its mechanism of action before starting the CTM application. CTM was performed by a trained physiotherapist as the patient was in a sitting position. Routine care and advising: In-bed activities were taught and recommended to the patients in both groups. In-bed activities; rotation, sitting on the bedside, breathing exercises, range of motion exercises for upper and lower extremities. In addition, hourly walking activities were recommended after the anesthetic effect wore off.

Behavioral: Routine care and advising
Routine care and advising: In-bed activities were taught and recommended to the patients in both groups. In-bed activities; rotation, sitting on the bedside, breathing exercises, range of motion exercises for upper and lower extremities. In addition, hourly walking activities were recommended after the anesthetic effect wore off.

Other: Total abdominal hysterectomy (TAH) control group

routine care+ advising

Behavioral: Routine care and advising
Routine care and advising: In-bed activities were taught and recommended to the patients in both groups. In-bed activities; rotation, sitting on the bedside, breathing exercises, range of motion exercises for upper and lower extremities. In addition, hourly walking activities were recommended after the anesthetic effect wore off.

Outcome Measures

Primary Outcome Measures

  1. Pain score [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 Outcome Measures

  1. time of the first passage of flatus after the surgery [Two days]

    time of the first passage of flatus after the surgery

  2. the time of the first defecation after the surgery [Two days]

    the time of the first defecation after the surgery

  3. blood pressure before and after interventions [Two days]

    Blood Pressure measurement before and after interventions (Systolic and Diastolic Pressure; in mmHg)

  4. Heart Rate before and after interventions [Two days]

    Heart Rate measurement before and after interventions (Beat per minute)

  5. Respiratory rates before and after interventions [Two days]

    Respiratory rates measurements (Breathing rate number per minute)

  6. The difficulty levels of the patients during functional activities [Two days]

    Assess with scoring to perceived difficulty. Patients scores difficulty in their activities of daily living 0 to 10. 0 means no difficulty, 10 means highest difficulty, very diffuculty performing activity

Eligibility Criteria

Criteria

Ages Eligible for Study:
41 Years to 53 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yozgat Bozok University Yozgat Turkey 66000

Sponsors and Collaborators

  • Bozok University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
hanife dogan, Assistant Professor, Bozok University
ClinicalTrials.gov Identifier:
NCT05270447
Other Study ID Numbers:
  • 20-KAEK-177
First Posted:
Mar 8, 2022
Last Update Posted:
Mar 8, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 8, 2022