Short-Term Effects of Connective Tissue Massage After Hysterectomy

NCT05270447 | Completed

• 1 other identifier: 20-KAEK-177
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Massage; Hysterectomy; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• time of the first passage of flatus after the surgery

  Two days

• the time of the first defecation after the surgery

  Two days

• blood pressure before and after interventions

  Two days

• Heart Rate before and after interventions

  Two days

• Respiratory rates before and after interventions

  Two days

Study Arms (4)

Total laparoscopic hysterectomy (TLH) Connetive tissue massage group

EXPERIMENTAL

Connective tissue massage+ routine care+ advising

Other: Massage and patient education; Behavioral: Routine care and advising

Total laparoscopic hysterectomy (TLH) control group

OTHER

routine care+ advising

Behavioral: Routine care and advising

Total abdominal hysterectomy (TAH) Connetive tissue massage group

EXPERIMENTAL

Connective tissue massage+ routine care+ advising

Other: Massage and patient education; Behavioral: Routine care and advising

Total abdominal hysterectomy (TAH) control group

OTHER

routine care+ advising

Behavioral: Routine care and advising

Interventions

Massage and patient education OTHER

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.

Total abdominal hysterectomy (TAH) Connetive tissue massage group; Total laparoscopic hysterectomy (TLH) Connetive tissue massage group

Routine care and advising BEHAVIORAL

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.

Total abdominal hysterectomy (TAH) Connetive tissue massage group; Total abdominal hysterectomy (TAH) control group; Total laparoscopic hysterectomy (TLH) Connetive tissue massage group; Total laparoscopic hysterectomy (TLH) control group

Eligibility Criteria

• Age: 41 Years - 53 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bozok University: lead

Study Sites (1)

Yozgat Bozok University

Yozgat, 66000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Massage; Patient Education as Topic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized Controlled Study

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 8, 2022
• Study Start: October 12, 2020
• Primary Completion: January 10, 2021
• Study Completion: March 1, 2021
• Last Updated: March 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)