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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
progressive muscle relaxation
Usual care
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Progressive Muscle Relaxation on Postoperative Pain, Fatigue, and Vital Signs in Patients With Head and Neck Cancers focused on measuring progressive muscle relaxation, head and neck cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    progressive muscle relaxation

    usual care

    Arm Description

    progressive muscle relaxation tape guided

    usual care

    Outcomes

    Primary Outcome Measures

    Pain level change
    The VAS (visual analog scale) score of pain levels, range 0-100, higher score means more severe symptoms.
    muscle tightness level change
    The VAS (visual analog scale) score of muscle tightness levels, range 0-100, higher score means more severe symptoms.
    Fatigue levels change
    The VAS (visual analog scale) score of fatigue levels, range 0-100, higher score means more severe symptoms.

    Secondary Outcome Measures

    Heart rate change
    Heart rate change
    Systolic blood pressure change
    Systolic blood pressure change
    Diastolic blood pressure change
    Diastolic blood pressure change
    Anxiety level
    The VAS (visual analog scale) score of Anxiety levels, range 0-100, higher score means more severe symptoms.
    depression level
    The VAS (visual analog scale) score of depression levels, range 0-100, higher score means more severe symptoms.
    sleep disturbance level
    The VAS (visual analog scale) score of sleep disturbance levels, range 0-100, higher score means more severe symptoms.

    Full Information

    First Posted
    April 12, 2021
    Last Updated
    April 12, 2021
    Sponsor
    Taipei Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04845009
    Brief Title
    Relaxation Therapy for Pain, Fatigue and Vital Signs in Post-operation With Head and Neck Cancer
    Official Title
    The Effectiveness of Progressive Muscle Relaxation on Postoperative Pain, Fatigue, and Vital Signs in Patients With Head and Neck Cancers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2015 (Actual)
    Primary Completion Date
    May 20, 2016 (Actual)
    Study Completion Date
    May 20, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taipei Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    67 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    progressive muscle relaxation
    Arm Type
    Experimental
    Arm Description
    progressive muscle relaxation tape guided
    Arm Title
    usual care
    Arm Type
    Placebo Comparator
    Arm Description
    usual care
    Intervention Type
    Behavioral
    Intervention Name(s)
    progressive muscle relaxation
    Intervention Description
    progressive muscle relaxation
    Intervention Type
    Behavioral
    Intervention Name(s)
    Usual care
    Intervention Description
    Usual care
    Primary Outcome Measure Information:
    Title
    Pain level change
    Description
    The VAS (visual analog scale) score of pain levels, range 0-100, higher score means more severe symptoms.
    Time Frame
    preoperative day to postoperative day 10
    Title
    muscle tightness level change
    Description
    The VAS (visual analog scale) score of muscle tightness levels, range 0-100, higher score means more severe symptoms.
    Time Frame
    preoperative day to postoperative day 10
    Title
    Fatigue levels change
    Description
    The VAS (visual analog scale) score of fatigue levels, range 0-100, higher score means more severe symptoms.
    Time Frame
    preoperative day to postoperative day 10
    Secondary Outcome Measure Information:
    Title
    Heart rate change
    Description
    Heart rate change
    Time Frame
    preoperative day to postoperative day 10
    Title
    Systolic blood pressure change
    Description
    Systolic blood pressure change
    Time Frame
    preoperative day to postoperative day 10
    Title
    Diastolic blood pressure change
    Description
    Diastolic blood pressure change
    Time Frame
    preoperative day to postoperative day 10
    Title
    Anxiety level
    Description
    The VAS (visual analog scale) score of Anxiety levels, range 0-100, higher score means more severe symptoms.
    Time Frame
    preoperative day to postoperative day 10
    Title
    depression level
    Description
    The VAS (visual analog scale) score of depression levels, range 0-100, higher score means more severe symptoms.
    Time Frame
    preoperative day to postoperative day 10
    Title
    sleep disturbance level
    Description
    The VAS (visual analog scale) score of sleep disturbance levels, range 0-100, higher score means more severe symptoms.
    Time Frame
    preoperative day to postoperative day 10

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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