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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Behavioral: progressive muscle relaxation
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: progressive muscle relaxation<br>progressive muscle relaxation tape guided | Behavioral: progressive muscle relaxation<br>* progressive muscle relaxation<br>|
| Placebo Comparator: usual care<br>usual care | Behavioral: Usual care<br>* Usual care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level change | 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 | 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 | 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 | Heart rate change | preoperative day to postoperative day 10 | 
| Systolic blood pressure change | Systolic blood pressure change | preoperative day to postoperative day 10 | 
| Diastolic blood pressure change | Diastolic blood pressure change | preoperative day to postoperative day 10 | 
| Anxiety level | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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progressive muscle relaxation, head and neck cancer