Short-Term Effects of Connective Tissue Massage After Hysterectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Hysterectomy; Massage
• Intervention / Treatment: Other: Massage and patient education; Behavioral: Routine care and advising

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Yozgat, Turkey, 66000
    • Yozgat Bozok University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	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.	Change from baseline to postoperative 2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time of the first passage of flatus after the surgery	time of the first passage of flatus after the surgery	Two days
the time of the first defecation after the surgery	the time of the first defecation after the surgery	Two days
blood pressure before and after interventions	Blood Pressure measurement before and after interventions (Systolic and Diastolic Pressure; in mmHg)	Two days
Heart Rate before and after interventions	Heart Rate measurement before and after interventions (Beat per minute)	Two days
Respiratory rates before and after interventions	Respiratory rates measurements (Breathing rate number per minute)	Two days
The difficulty levels of the patients during functional activities	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	Two days

Collaborators and Investigators

• Sponsor: Bozok University

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2020
• Primary Completion (Actual): January 10, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: February 26, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: February 26, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 20-KAEK-177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No