Skip to main content
OpenTrials
Completed

NCT Number: NCT04845009

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Progressive Muscle Relaxation

Behavioral

progressive muscle relaxation

Usual Care

Behavioral

Usual care

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Heart rate change

    Time frame: preoperative day to postoperative day 10

    Heart rate change

  2. Systolic blood pressure change

    Time frame: preoperative day to postoperative day 10

    Systolic blood pressure change

  3. Diastolic blood pressure change

    Time frame: preoperative day to postoperative day 10

    Diastolic blood pressure change

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 14, 2021
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.