Short-Term Effects of Connective Tissue Massage After Hysterectomy

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05270447
• Other study ID #: 20-KAEK-177
• Status: Completed
• Phase: N/A
• Start date: October 12, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: February 2022
• Source: Bozok University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2021
• Est. primary completion date: January 10, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 41 Years to 53 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hysterectomy
• Massage
• Pain

Intervention

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.

Locations

Country	Name	City	State
Turkey	Yozgat Bozok University	Yozgat

Sponsors (1)

Lead Sponsor	Collaborator
Bozok University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	time of the first passage of flatus after the surgery	time of the first passage of flatus after the surgery	Two days
Secondary	the time of the first defecation after the surgery	the time of the first defecation after the surgery	Two days
Secondary	blood pressure before and after interventions	Blood Pressure measurement before and after interventions (Systolic and Diastolic Pressure; in mmHg)	Two days
Secondary	Heart Rate before and after interventions	Heart Rate measurement before and after interventions (Beat per minute)	Two days
Secondary	Respiratory rates before and after interventions	Respiratory rates measurements (Breathing rate number per minute)	Two days
Secondary	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