Effects of Connective Tissue Massage on Pain After Thoracotomy

Postoperative Pain Clinical Trial

Official title:

Examining the Effects of Connective Tissue Massage on Pain After Thoracotomy - Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05617937
• Other study ID #: AkdenizUniversitythoracic
• Status: Completed
• Phase: N/A
• Start date: April 23, 2021
• Est. completion date: November 1, 2022

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 1, 2022
• Est. primary completion date: October 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Other:
• Massage
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.

Locations

Country	Name	City	State
Turkey	Neriman Temel Aksu	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 from Baseline Pain Score at 7 days.
Primary	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.	Change from Baseline applied analgesic amounts of the patients at 7 days.
Secondary	Height in Meters	The height of all subjects in meters (m) will be noted before the surgery.	Initial assessment before surgery.
Secondary	Weight in Kilograms	The weight of all subjects in kilograms (kg) will be noted before the surgery.	Initial assessment before surgery.
Secondary	Body Mass Index (BMI) in kg/m^2	Body Mass Index (BMI) will be calculated with the formula weight (kg)/height (m)^2.	Initial assessment before surgery.