NCT05617937

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

April 23, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 16, 2022

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

1.5 years

First QC Date

March 23, 2021

Last Update Submit

November 8, 2022

Conditions

Postoperative Pain

Keywords

Connective tissue massageThoracotomyPain

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (3)

  • Height in Meters

    Initial assessment before surgery.

  • Weight in Kilograms

    Initial assessment before surgery.

  • Body Mass Index (BMI) in kg/m^2

    Initial assessment before surgery.

Study Arms (2)

Connective tissue massage gruop

EXPERIMENTAL

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.

Other: Massage

Conventional Physiotherapy and Rehabilitation Group

NO INTERVENTION

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

Interventions

MassageOTHER

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.

Connective tissue massage gruop

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neriman Temel Aksu

Antalya, 07060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

Massage

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Neriman Aksu

    Akdeniz Üniversitesi Antalya Sağlık Yüksekokulu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 23, 2021

First Posted

November 16, 2022

Study Start

April 23, 2021

Primary Completion

October 22, 2022

Study Completion

November 1, 2022

Last Updated

November 16, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)