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Completed

NCT Number: NCT05270447

Short-Term Effects of Connective Tissue Massage After Hysterectomy

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.

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Key information

Age range

41 year–53 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yozgat Bozok University

Yozgat, 66000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. time of the first passage of flatus after the surgery

    Time frame: Two days

    time of the first passage of flatus after the surgery

  2. the time of the first defecation after the surgery

    Time frame: Two days

    the time of the first defecation after the surgery

  3. blood pressure before and after interventions

    Time frame: Two days

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

  4. Heart Rate before and after interventions

    Time frame: Two days

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

  5. Respiratory rates before and after interventions

    Time frame: Two days

    Respiratory rates measurements (Breathing rate number per minute)

  6. The difficulty levels of the patients during functional activities

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bozok University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 8, 2022
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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