Short-Term Effects of Connective Tissue Massage After Hysterectomy

NCT ID: NCT05270447

Last Updated: 2022-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-12

Study Completion Date

2021-03-01

Brief Summary

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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

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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.

Conditions

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Massage Hysterectomy Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Total laparoscopic hysterectomy (TLH) Connetive tissue massage group

Connective tissue massage+ routine care+ advising

Group Type EXPERIMENTAL

Massage and patient education

Intervention Type 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.

Routine care and advising

Intervention Type 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 laparoscopic hysterectomy (TLH) control group

routine care+ advising

Group Type OTHER

Routine care and advising

Intervention Type 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

Connective tissue massage+ routine care+ advising

Group Type EXPERIMENTAL

Massage and patient education

Intervention Type 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.

Routine care and advising

Intervention Type 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) control group

routine care+ advising

Group Type OTHER

Routine care and advising

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

41 Years

Maximum Eligible Age

53 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bozok University

OTHER

Sponsor Role lead

Responsible Party

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hanife dogan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yozgat Bozok University

Yozgat, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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20-KAEK-177

Identifier Type: -

Identifier Source: org_study_id

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