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

NCT ID: NCT04845009

Last Updated: 2021-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-01

Study Completion Date

2016-05-20

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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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progressive muscle relaxation

progressive muscle relaxation tape guided

Group Type EXPERIMENTAL

progressive muscle relaxation

Intervention Type BEHAVIORAL

progressive muscle relaxation

usual care

usual care

Group Type PLACEBO_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

Usual care

Interventions

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progressive muscle relaxation

progressive muscle relaxation

Intervention Type BEHAVIORAL

Usual care

Usual care

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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relaxation for HN

Identifier Type: -

Identifier Source: org_study_id

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