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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04845009
Other study ID # relaxation for HN
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2015
Est. completion date May 20, 2016

Study information

Verified date April 2021
Source Taipei Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date May 20, 2016
Est. primary completion date May 20, 2016
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
progressive muscle relaxation
progressive muscle relaxation
Usual care
Usual care

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Heart rate change Heart rate change preoperative day to postoperative day 10
Secondary Systolic blood pressure change Systolic blood pressure change preoperative day to postoperative day 10
Secondary Diastolic blood pressure change Diastolic blood pressure change preoperative day to postoperative day 10
Secondary 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
Secondary 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
Secondary 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