Clinical trial NCT05270447: Short-Term Effects of Connective Tissue Massage After Hysterectomy
Official title: Short-Term Effects of Connective Tissue Massage After Hysterectomy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Massage
Hysterectomy
Pain
Lead sponsor: Bozok University
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 41
Maximum age (years): 53
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Study
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain score
timeFrame: Change from baseline to postoperative 2 days
Secondary outcomes:
measure: time of the first passage of flatus after the surgery
timeFrame: Two days
measure: the time of the first defecation after the surgery
timeFrame: Two days
measure: blood pressure before and after interventions
timeFrame: Two days
measure: Heart Rate before and after interventions
timeFrame: Two days
measure: Respiratory rates before and after interventions
timeFrame: Two days
measure: The difficulty levels of the patients during functional activities
timeFrame: Two days
Other outcomes:
Locations:
city: Yozgat
country: Turkey
facility: Yozgat Bozok University
Study officials:
References: