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Effects of Connective Tissue Massage on Pain After Thoracotomy

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Massage
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postoperative Pain focused on measuring Connective tissue massage, Thoracotomy, Pain

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Applying to Thoracic Surgery Department of Akdeniz University Hospital and undergoing thoracotomy via posterolateral thoracotomy incision, Being in age range of 20-75 years, Being stable in terms of hemodynamics, Having no metastatic dissemination, Having no known cerebrovascular disease, Having no morbid obesity and heart disease that may inhibit the study, Having no cognitive impairment that may inhibit communication, Having no previous stroke and the associated influence, Having no inconvenience for connective tissue massage as a result of the evaluation made by the physician, Agreeing to participate in the study. Exclusion Criteria: Having cardiovascular diseases, Having stage 3 (severe) or stage 4 (very severe) chronic obstructive pulmonary disease (COPD), Having more than 200 cc bleeding per hour from the drainage tubes, Having an intubation period longer than 24 hours, Interventions having a negative effect on the pain such as decortication, diaphragm eventration, thoracic wall resection that are performed by thoracotomy were excluded from in the study.

Sites / Locations

  • Neriman Temel Aksu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Connective tissue massage gruop

Conventional Physiotherapy and Rehabilitation Group

Arm Description

In addition, a total of 5 sessions of connective tissue massage were applied to the experimental group as 1 session a day on the postoperative 1st day, 2nd day, 3rd day, 4th day, 5th day. Connective tissue massage was only performed to the patients in the experimental group. A total of 5 sessions of connective tissue massage were applied to the experimental group as 1 session a day on the postoperative 1st day, 2nd day, 3rd day, 4th day, 5th day. Depending on the area of procedure, each session varied between 15 minutes and 20 minutes.

Standard medical treatment, care and pulmonary rehabilitation program were applied to bonventional Physiotherapy and Rehabilitation Group.The patients were mobilized as early as possible. Starting on the postoperative zeroth day, a postoperative rehabilitation program including pulmonary rehabilitation and early mobilization was applied to every patient in the control and experimental groups by a therapist for 1 week as in routine

Outcomes

Primary Outcome Measures

Change of Pain Score
On postoperative 0th day, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day and 7th day (before the massage in the experimental group) (between 8.00 and 9.00 in the morning); in other words, pain level of the patients (n=54) was evaluated at every 24 hours as of the zeroth postoperative day.
Change of applied analgesic amounts of the patients
Totally applied analgesic amounts of the patients were recorded on the postoperative 0th day, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, and 7th day. In addition, length of hospitalization of the patients was recorded.

Secondary Outcome Measures

Height in Meters
The height of all subjects in meters (m) will be noted before the surgery.
Weight in Kilograms
The weight of all subjects in kilograms (kg) will be noted before the surgery.
Body Mass Index (BMI) in kg/m^2
Body Mass Index (BMI) will be calculated with the formula weight (kg)/height (m)^2.

Full Information

First Posted
March 23, 2021
Last Updated
November 8, 2022
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT05617937
Brief Title
Effects of Connective Tissue Massage on Pain After Thoracotomy
Official Title
Examining the Effects of Connective Tissue Massage on Pain After Thoracotomy - Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 23, 2021 (Actual)
Primary Completion Date
October 22, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Pain can be quite severe after thoracic surgery and effective pain control is highly effective in preventing secretion accumulation, atelectasis, infection and hypoxemia. The objective was evaluate the effect of a connective tissue massage on pain, applied analgesic amounts and length of hospitalization of the patients.The study was conducted at a thoracic surgery department of university hospital in Turkey. Fifty-four patients with operated by the posterolateral thoracotomy method participated.The patients were randomly allocated to 1 of 2 groups: a control group (n27) and the experimental group (n27). Standard medical treatment, care and pulmonary rehabilitation program were applied to both groups. In addition, a total of 5 sessions of connective tissue massage were applied to the experimental group. Pain level of the patients was evaluated at every 24 hours as of the zeroth postoperative day. VAS was used as a one-dimensional scale for pain assessment. Totally applied analgesic amounts and length of hospitalization of the patients were recorded.
Detailed Description
The patients were randomly divided into two groups as the control group and the experimental group by using the Microsoft Excel program (Microsoft Inc., Redmond, WA, USA). The population of the study consisted of the patients who were hospitalized at Thoracic Surgery Clinic and operated by the posterolateral thoracotomy method. The first group of the study consisted of the patients in the control group and the second group consisted of the connective tissue massage group. Lobectomy, pneumonectomy, segmentectomy or wedge resection surgeries were performed together with posterolateral thoracotomy in both patient groups. Standard medical treatment, care and pulmonary rehabilitation program were applied to both groups. The patients were mobilized as early as possible. Starting on the postoperative zeroth day, a postoperative rehabilitation program including pulmonary rehabilitation and early mobilization was applied to every patient in the control and experimental groups by a therapist for 1 week as in routine. In addition, a total of 5 sessions of connective tissue massage were applied to the experimental group as 1 session a day on the postoperative 1st day, 2nd day, 3rd day, 4th day, 5th day. Connective tissue massage was only performed to the patients in the experimental group. The procedure was performed while the patient was in the sitting position on a chair. In order to provide relaxation in the connective tissue, the patient was asked to perform a slight anterior tilt and to hold his back upright. The middle fingers were used bilaterally in order to provide traction between the cutaneous tissues. In order to prevent contraindication, the procedure was applied to the tissues that were 2 inch away from the surgical site. Throughout the procedure, oxygen saturation of the patient, if required, the heart rate and blood pressure were followed up. The connective tissue massage was started from the lumbosacral region (baseline) and was applied to the lower thoracic, scapular, inter-scapular and cervico-occipital region according to the vascular response of the connective tissue. A total of 5 sessions of connective tissue massage were applied to the experimental group as 1 session a day on the postoperative 1st day, 2nd day, 3rd day, 4th day, 5th day. Depending on the area of procedure, each session varied between 15 minutes and 20 minutes. On postoperative 0th day, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day and 7th day (before the massage in the experimental group) (between 8.00 and 9.00 in the morning); in other words, pain level of the patients (n=54) was evaluated at every 24 hours as of the zeroth postoperative day. Totally applied analgesic amounts of the patients were recorded on the postoperative 0th day, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, and 7th day. In addition, length of hospitalization of the patients was recorded.In the present study, it was found that the patients with prolonged hospitalization period had higher postoperative pain and the duration of hospitalization was longer in the control group. It was thought that this difference was caused by the effects of connective tissue massage on pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Connective tissue massage, Thoracotomy, Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Connective tissue massage gruop
Arm Type
Experimental
Arm Description
In addition, a total of 5 sessions of connective tissue massage were applied to the experimental group as 1 session a day on the postoperative 1st day, 2nd day, 3rd day, 4th day, 5th day. Connective tissue massage was only performed to the patients in the experimental group. A total of 5 sessions of connective tissue massage were applied to the experimental group as 1 session a day on the postoperative 1st day, 2nd day, 3rd day, 4th day, 5th day. Depending on the area of procedure, each session varied between 15 minutes and 20 minutes.
Arm Title
Conventional Physiotherapy and Rehabilitation Group
Arm Type
No Intervention
Arm Description
Standard medical treatment, care and pulmonary rehabilitation program were applied to bonventional Physiotherapy and Rehabilitation Group.The patients were mobilized as early as possible. Starting on the postoperative zeroth day, a postoperative rehabilitation program including pulmonary rehabilitation and early mobilization was applied to every patient in the control and experimental groups by a therapist for 1 week as in routine
Intervention Type
Other
Intervention Name(s)
Massage
Intervention Description
The connective tissue massage was started from the lumbosacral region (baseline) and was applied to the lower thoracic, scapular, inter-scapular and cervico-occipital region according to the vascular response of the connective tissue.
Primary Outcome Measure Information:
Title
Change of Pain Score
Description
On postoperative 0th day, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day and 7th day (before the massage in the experimental group) (between 8.00 and 9.00 in the morning); in other words, pain level of the patients (n=54) was evaluated at every 24 hours as of the zeroth postoperative day.
Time Frame
Change from Baseline Pain Score at 7 days.
Title
Change of applied analgesic amounts of the patients
Description
Totally applied analgesic amounts of the patients were recorded on the postoperative 0th day, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, and 7th day. In addition, length of hospitalization of the patients was recorded.
Time Frame
Change from Baseline applied analgesic amounts of the patients at 7 days.
Secondary Outcome Measure Information:
Title
Height in Meters
Description
The height of all subjects in meters (m) will be noted before the surgery.
Time Frame
Initial assessment before surgery.
Title
Weight in Kilograms
Description
The weight of all subjects in kilograms (kg) will be noted before the surgery.
Time Frame
Initial assessment before surgery.
Title
Body Mass Index (BMI) in kg/m^2
Description
Body Mass Index (BMI) will be calculated with the formula weight (kg)/height (m)^2.
Time Frame
Initial assessment before surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Applying to Thoracic Surgery Department of Akdeniz University Hospital and undergoing thoracotomy via posterolateral thoracotomy incision, Being in age range of 20-75 years, Being stable in terms of hemodynamics, Having no metastatic dissemination, Having no known cerebrovascular disease, Having no morbid obesity and heart disease that may inhibit the study, Having no cognitive impairment that may inhibit communication, Having no previous stroke and the associated influence, Having no inconvenience for connective tissue massage as a result of the evaluation made by the physician, Agreeing to participate in the study. Exclusion Criteria: Having cardiovascular diseases, Having stage 3 (severe) or stage 4 (very severe) chronic obstructive pulmonary disease (COPD), Having more than 200 cc bleeding per hour from the drainage tubes, Having an intubation period longer than 24 hours, Interventions having a negative effect on the pain such as decortication, diaphragm eventration, thoracic wall resection that are performed by thoracotomy were excluded from in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neriman Aksu
Organizational Affiliation
Akdeniz Üniversitesi Antalya Sağlık Yüksekokulu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neriman Temel Aksu
City
Antalya
ZIP/Postal Code
07060
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Connective Tissue Massage on Pain After Thoracotomy

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