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

Not Applicable

Completed

• Conditions: Progressive Muscle Relaxation on Postoperative Pain, Fatigue, and Vital Signs in Patients With Head and Neck Cancers
• Interventions: Behavioral: progressive muscle relaxation; Behavioral: Usual care

• Registration Number: NCT04845009
• Lead Sponsor: Taipei Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-01
• Primary Completion: 2016-05-20
• Study Completion: 2016-05-20
• Status Verified: 2021-04
• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-12
• Last Update Submitted: 2021-04-12
• Study First Posted: 2021-04-14
• Last Update Posted: 2021-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
progressive muscle relaxation	progressive muscle relaxation	progressive muscle relaxation tape guided
usual care	Usual care	usual care

Primary Outcome Measures

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

Secondary Outcome Measures

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