Relaxation Therapy for Pain, Fatigue and Vital Signs in Post-operation With Head and Neck Cancer

April 12, 2021 updated by: Taipei Medical University

The Effectiveness of Progressive Muscle Relaxation on Postoperative Pain, Fatigue, and Vital Signs in Patients With Head and Neck Cancers

This study aimed to investigate the effects of progressive muscle relaxation (PMR) on postoperative pain, fatigue, and vital signs in patients with head and neck cancers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Head and neck cancer, need for surgery.

(1) clear consciousness; (2) >= 20 years; (3) no history of surgery for head and neck cancer, regardless of cancer staging, tracheostomy tubing, degree of primary tumor resection, neck dissection, modified radical neck dissection, resection of cervical nerve root branches, and flap reconstruction (including free flap and transposition flap); (4) plan to undergo surgery; (5) willingness to participate in this study and provide informed consent; (6) physically capable of participation the study, as determined by the physician in charge; (7) ability to communicate in Mandarin or Taiwanese, with no reading, listening, or writing disability, and complete the questionnaire alone or with the assistance of the researchers.

Exclusion Criteria:

- Head and neck cancer, not for surgery.

(1) use of hypnotics or record of a sleep disorder within 3 months prior to admission; (2) difficulty hearing, external auditory canal trauma, or hearing impairment; (3) diagnosis of a psychotic disorder or cognitive impairment; (4) experience practicing Jacobson's PMR.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: progressive muscle relaxation
progressive muscle relaxation tape guided
Behavioral: progressive muscle relaxation
progressive muscle relaxation
Placebo Comparator: usual care
Behavioral: Usual care
Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level change
Time Frame: preoperative day to postoperative day 10
The VAS (visual analog scale) score of pain levels, range 0-100, higher score means more severe symptoms.
preoperative day to postoperative day 10
muscle tightness level change
Time Frame: preoperative day to postoperative day 10
The VAS (visual analog scale) score of muscle tightness levels, range 0-100, higher score means more severe symptoms.
preoperative day to postoperative day 10
Fatigue levels change
Time Frame: preoperative day to postoperative day 10
The VAS (visual analog scale) score of fatigue levels, range 0-100, higher score means more severe symptoms.
preoperative day to postoperative day 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate change
Time Frame: preoperative day to postoperative day 10
Heart rate change
preoperative day to postoperative day 10
Systolic blood pressure change
Time Frame: preoperative day to postoperative day 10
Systolic blood pressure change
preoperative day to postoperative day 10
Diastolic blood pressure change
Time Frame: preoperative day to postoperative day 10
Diastolic blood pressure change
preoperative day to postoperative day 10
Anxiety level
Time Frame: preoperative day to postoperative day 10
The VAS (visual analog scale) score of Anxiety levels, range 0-100, higher score means more severe symptoms.
preoperative day to postoperative day 10
depression level
Time Frame: preoperative day to postoperative day 10
The VAS (visual analog scale) score of depression levels, range 0-100, higher score means more severe symptoms.
preoperative day to postoperative day 10
sleep disturbance level
Time Frame: preoperative day to postoperative day 10
The VAS (visual analog scale) score of sleep disturbance levels, range 0-100, higher score means more severe symptoms.
preoperative day to postoperative day 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

May 20, 2016

Study Completion (Actual)

May 20, 2016

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

April 12, 2021

First Posted (Actual)

April 14, 2021

Study Record Updates

Last Update Posted (Actual)

April 14, 2021

Last Update Submitted That Met QC Criteria

April 12, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • relaxation for HN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Progressive Muscle Relaxation on Postoperative Pain, Fatigue, and Vital Signs in Patients With Head and Neck Cancers

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