Progressive Muscle Relaxation on Postoperative Pain, Fatigue, and Vital Signs in Patients With Head and Neck CancersNCT04845009
Relaxation Therapy for Pain, Fatigue and Vital Signs in Post-operation With Head and Neck Cancer
A study testing progressive muscle relaxation in people with Progressive Muscle Relaxation on Postoperative Pain, Fatigue, and Vital Signs in Patients With Head and Neck Cancers, run by Taipei Medical University.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Progressive Muscle Relaxation on Postoperative Pain, Fatigue, and Vital Signs in Patients With Head and Neck Cancers
- What is being tested?
- progressive muscle relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2015to 20 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Head and neck cancer, need for surgery.
- 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.
Who cannot join
- Head and neck cancer, not for surgery.
- 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.
About this study
Official title: The Effectiveness of Progressive Muscle Relaxation on Postoperative Pain, Fatigue, and Vital Signs in Patients With Head and Neck Cancers
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.
- Being tested
- progressive muscle relaxation, Usual care
- Keywords
- progressive muscle relaxation, head and neck cancer
- Medical subject headings
- Fatigue, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive muscle relaxationBehavioural
progressive muscle relaxation
Usual careBehavioural
Usual care
| Study group | Role | What they receive |
|---|---|---|
| progressive muscle relaxation | Experimental | progressive muscle relaxation tape guided Receives: Behavioral: progressive muscle relaxation |
| usual care | Placebo comparator | usual care Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level change
The VAS (visual analog scale) score of pain levels, range 0-100, higher score means more severe symptoms.
Measured: 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.
Measured: 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.
Measured: preoperative day to postoperative day 10
Secondary outcomes (6)
Heart rate change
Heart rate change
Measured: preoperative day to postoperative day 10
Systolic blood pressure change
Systolic blood pressure change
Measured: preoperative day to postoperative day 10
Diastolic blood pressure change
Diastolic blood pressure change
Measured: preoperative day to postoperative day 10
Anxiety level
The VAS (visual analog scale) score of Anxiety levels, range 0-100, higher score means more severe symptoms.
Measured: preoperative day to postoperative day 10
depression level
The VAS (visual analog scale) score of depression levels, range 0-100, higher score means more severe symptoms.
Measured: preoperative day to postoperative day 10
sleep disturbance level
The VAS (visual analog scale) score of sleep disturbance levels, range 0-100, higher score means more severe symptoms.
Measured: preoperative day to postoperative day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start1 May 2015
- Primary completion20 May 2016
- Study completion20 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Muscle Relaxation on Postoperative Pain, Fatigue, and Vital Signs in Patients With Head and Neck CancersStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845009
- Sponsor's protocol ID
- relaxation for HN
- Status last verified
- Apr 2021
- First submitted
- 12 Apr 2021
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Progressive Muscle Relaxation on Postoperative Pain, Fatigue, and Vital Signs in Patients With Head and Neck Cancers
- ClinicalTrials.gov ID
- NCT04845009
- Acronym / sponsor ID
- relaxation for HN
- Keywords
- progressive muscle relaxation, head and neck cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 20 May 2016 (actual)
- Study completion
- 20 May 2016 (actual)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| progressive muscle relaxation | Experimental | Behavioral: progressive muscle relaxationprogressive muscle relaxation tape guided |
| usual care | Placebo comparator | Behavioral: Usual careusual care |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Head and neck cancer, need for surgery.
- 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.
Key exclusion criteria (2 listed)
- Head and neck cancer, not for surgery.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| progressive muscle relaxationprogressive muscle relaxation | Behavioural | progressive muscle relaxation |
| Usual careUsual care | Behavioural | usual care |
Primary outcome
Pain level change
Time frame: preoperative day to postoperative day 10
The VAS (visual analog scale) score of pain levels, range 0-100, higher score means more severe symptoms.
muscle tightness level change
Time frame: preoperative day to postoperative day 10
The VAS (visual analog scale) score of muscle tightness levels, range 0-100, higher score means more severe symptoms.
Fatigue levels change
Time frame: preoperative day to postoperative day 10
The VAS (visual analog scale) score of fatigue levels, range 0-100, higher score means more severe symptoms.
6 secondary outcomes
Heart rate change
Time frame: preoperative day to postoperative day 10
Systolic blood pressure change
Time frame: preoperative day to postoperative day 10
Diastolic blood pressure change
Time frame: preoperative day to postoperative day 10
Anxiety level
Time frame: preoperative day to postoperative day 10
depression level
Time frame: preoperative day to postoperative day 10
sleep disturbance level
Time frame: preoperative day to postoperative day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing progressive muscle relaxation in people with Progressive Muscle Relaxation on Postoperative Pain, Fatigue, and Vital Signs in Patients With Head and Neck Cancers, run by Taipei Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level change (time frame: preoperative day to postoperative day 10). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.