NCT04845009

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2016

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

1.1 years

First QC Date

April 12, 2021

Last Update Submit

April 12, 2021

Conditions

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

Keywords

progressive muscle relaxationhead and neck cancer

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • Heart rate change

    preoperative day to postoperative day 10

  • Systolic blood pressure change

    preoperative day to postoperative day 10

  • Diastolic blood pressure change

    preoperative day to postoperative day 10

  • Anxiety level

    preoperative day to postoperative day 10

  • depression level

    preoperative day to postoperative day 10

  • +1 more secondary outcomes

Study Arms (2)

progressive muscle relaxation

EXPERIMENTAL

progressive muscle relaxation tape guided

Behavioral: progressive muscle relaxation

usual care

PLACEBO COMPARATOR

usual care

Behavioral: Usual care

Interventions

progressive muscle relaxationBEHAVIORAL

progressive muscle relaxation

progressive muscle relaxation
Usual careBEHAVIORAL

Usual care

usual care

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

FatigueHead and Neck Neoplasms

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 14, 2021

Study Start

May 1, 2015

Primary Completion

May 20, 2016

Study Completion

May 20, 2016

Last Updated

April 14, 2021

Record last verified: 2021-04