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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04845009
Enrollment
67
Registered
2021-04-14
Start date
2015-05-01
Completion date
2016-05-20
Last updated
2021-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

progressive muscle relaxation, head and neck cancer

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.

Interventions

BEHAVIORALprogressive muscle relaxation

progressive muscle relaxation

BEHAVIORALUsual care

Usual care

Sponsors

Taipei Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026