Burn Degree SecondNCT04200053
The Effect of Reflexology Massage and Passive Music Therapy Intervention Before Burn Dressing
A study testing Reflexology massage and Reflexology massage and passive music in people with Burn Degree Second and Burn Degree Third, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Reflexology massage applied before burn dressing reduces pain, anxiety and sleep problems Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn Degree Second, Burn Degree Third
- What is being tested?
- Reflexology massage and Reflexology massage and passive music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Aug 2019to 7 Mar 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years,
- illiterate,
- without any mental and psychological disease and able to communicate with the assessor
- no hearing problems,
- moderate or severe burns,
- 2 days or more after burn injury,
Show all 13Show fewer
- proliferation phase of wound healing,
- No open wound, infection or circulatory problems in the area where reflexology will be applied.
- Not having diabetes,
- not using any pre-dressing complementary medicine,
- non-pregnant,
- having no pacemaker,
- agreeing to participate in the study.
Who cannot join
- Patients who do not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Reflexology Massage and Passive Music Therapy Intervention Before Burn Dressing on Pain, Anxiety Level and Sleep Quality
Reflexology massage applied before burn dressing reduces pain, anxiety and sleep problems
Read the detailed description
Reflexology massage regulates blood circulation and energy, gives a feeling of relaxation and provides homeostasis. During reflexology massage, relaxation music is recommended because it contributes to the relaxation of the individual. In the literature, reflexology massage and music therapy are used in different pain management, and these methods reduce anxiety and improve sleep quality. However, there is no study in which reflexology massage and passive music therapy are used to reduce pain, anxiety and sleep problems associated with dressing of burn individuals. It is thought that reflexology massage and passive music therapy will reduce pain, anxiety and sleep problems in dressing changes of burned individuals.
- Conditions
- Burn Degree Second, Burn Degree Third
- Being tested
- Reflexology massage, Reflexology massage and passive music
- Keywords
- burn, reflexology, music, pain, anxiety, sleep
- Medical subject headings
- Burns, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reflexology massageOther
Before the burn dressing, a reflexology massage will be performed for 20 minutes on the right foot and 20 minutes on the left foot. This intervention will continue in the morning for 3 days.
Reflexology massage and passive musicOther
Before the burn dressing, a reflexology massage and passive music will be performed for 20 minutes on the right foot and 20 minutes on the left foot. Instrumental music will be played during the massage. This intervention will continue in the morning for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Reflexology massage | Experimental | Reflexology massage Receives: Other: Reflexology massage |
| Reflexology massage and passive music | Experimental | Reflexology massage and passive music Receives: Other: Reflexology massage and passive music |
| Control | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
The effect of reflexology massage and passive music on pain before burn dressing. The scale used is a scale in which the individual can score himself / herself. "0" means no pain, "10" means pain as bad as can be. In the study, patients' pain will be evaluated for 4 days before and after dressing.
Measured: 4 days
Anxiety level
The effect of reflexology massage and passive music on anxiety before burn dressing. Anxiety of patients will be measured with Visual analog scale, State-Trait Anxiety Inventory.The Anxiety Inventory consists of two different sections and contains a total of 40 items, 20 each. Each item is scored between 1 and 4. A high score indicates that anxiety level is high. In the study, patients' anxiety will be evaluated for 4 days before and after dressing
Measured: 4 days
Sleep quality
The effect of reflexology massage and passive music on sleep qualty before burn dressing. Sleep quality of patients will be measured by Richard-Campbell Sleep Questionnaire.Each item of the scale is evaluated between 0-100. 0-25 points indicate "very bad sleep" and 76-100 points indicate "very good sleep". The higher the scale score, the higher the sleep quality of the patient. In the study, patients' sleep will be evaluated for 4 days before and after dressing
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start12 Aug 2019
- Primary completion7 Mar 2020
- Study completion7 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Burn Degree SecondStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Model description
- Grup 1: Reflexology massage group Grup 2: Reflexology massage and pasiive music group Grup 3: Control group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Kabuk, RN, PhD, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200053
- Status last verified
- Apr 2022
- First submitted
- 21 Nov 2019
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The work is still underway and is being monitored by a committee. It is also a doctoral thesis. Necessary comments will be received and then shared.
Publications
Molavi Vardanjani M, Masoudi Alavi N, Razavi NS, Aghajani M, Azizi-Fini E, Vaghefi SM. A randomized-controlled trial examining the effects of reflexology on anxiety of patients undergoing coronary angiography. Nurs Midwifery Stud. 2013 Sep;2(3):3-9. doi: 10.5812/nms.12167. Epub 2013 Sep 15.
PubMed 25414869Rohilla L, Agnihotri M, Trehan SK, Sharma RK, Ghai S. Effect of Music Therapy on Pain Perception, Anxiety, and Opioid Use During Dressing Change Among Patients With Burns in India: A Quasi-experimental, Cross-over Pilot Study. Ostomy Wound Manage. 2018 Oct;64(10):40-46.
PubMed 30312157Rafii F, Mohammadi-Fakhar F, Jamshidi Orak R. Effectiveness of jaw relaxation for burn dressing pain: randomized clinical trial. Pain Manag Nurs. 2014 Dec;15(4):845-53. doi: 10.1016/j.pmn.2013.11.001. Epub 2014 Apr 24.
PubMed 24767806
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reflexology Massage and Passive Music Therapy Intervention Before Burn Dressing on Pain, Anxiety Level and Sleep Quality
- ClinicalTrials.gov ID
- NCT04200053
- Conditions
- Burn Degree Second, Burn Degree Third
- Keywords
- burn, reflexology, music, pain, anxiety, sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 7 Mar 2020 (actual)
- Study completion
- 7 Mar 2020 (actual)
- First posted
- 16 Dec 2019 (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.
Reflexology massage applied before burn dressing reduces pain, anxiety and sleep problems
Detailed description
Reflexology massage regulates blood circulation and energy, gives a feeling of relaxation and provides homeostasis. During reflexology massage, relaxation music is recommended because it contributes to the relaxation of the individual. In the literature, reflexology massage and music therapy are used in different pain management, and these methods reduce anxiety and improve sleep quality. However, there is no study in which reflexology massage and passive music therapy are used to reduce pain, anxiety and sleep problems associated with dressing of burn individuals. It is thought that reflexology massage and passive music therapy will reduce pain, anxiety and sleep problems in dressing changes of burned individuals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Grup 1: Reflexology massage group Grup 2: Reflexology massage and pasiive music group Grup 3: Control group
| Arm | Type | Receives |
|---|---|---|
| Reflexology massage | Experimental | Other: Reflexology massageReflexology massage |
| Reflexology massage and passive music | Experimental | Other: Reflexology massage and passive musicReflexology massage and passive music |
| Control | No intervention | –Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Over 18 years,
- illiterate,
- without any mental and psychological disease and able to communicate with the assessor
- no hearing problems,
- moderate or severe burns,
Key exclusion criteria (1 listed)
- Patients who do not meet the inclusion criteria.
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 |
|---|---|---|
| Reflexology massageBefore the burn dressing, a reflexology massage will be performed for 20 minutes on the right foot and 20 minutes on the left foot. This intervention will continue in the morning for 3 days. | Other | Reflexology massage |
| Reflexology massage and passive musicBefore the burn dressing, a reflexology massage and passive music will be performed for 20 minutes on the right foot and 20 minutes on the left foot. Instrumental music will be played during the massage. This intervention will continue in the morning for 3 days. | Other | Reflexology massage and passive music |
Primary outcome
Pain level
Time frame: 4 days
The effect of reflexology massage and passive music on pain before burn dressing. The scale used is a scale in which the individual can score himself / herself. "0" means no pain, "10" means pain as bad as can be. In the study, patients' pain will be evaluated for 4 days before and after dressing.
Anxiety level
Time frame: 4 days
The effect of reflexology massage and passive music on anxiety before burn dressing. Anxiety of patients will be measured with Visual analog scale, State-Trait Anxiety Inventory.The Anxiety Inventory consists of two different sections and contains a total of 40 items, 20 each. Each item is scored between 1 and 4. A high score indicates that anxiety level is high. In the study, patients' anxiety will be evaluated for 4 days before and after dressing
Sleep quality
Time frame: 4 days
The effect of reflexology massage and passive music on sleep qualty before burn dressing. Sleep quality of patients will be measured by Richard-Campbell Sleep Questionnaire.Each item of the scale is evaluated between 0-100. 0-25 points indicate "very bad sleep" and 76-100 points indicate "very good sleep". The higher the scale score, the higher the sleep quality of the patient. In the study, patients' sleep will be evaluated for 4 days before and after dressing
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 26 Apr 2022.
- Background: PubMed 25414869Molavi Vardanjani M, Masoudi Alavi N, Razavi NS, Aghajani M, Azizi-Fini E, Vaghefi SM. A randomized-controlled trial examining the effects of reflexology on anxiety of patients undergoing coronary angiography. Nurs Midwifery Stud. 2013 Sep;2(3):3-9. doi: 10.5812/nms.12167. Epub 2013 Sep 15.
- Background: PubMed 30312157Rohilla L, Agnihotri M, Trehan SK, Sharma RK, Ghai S. Effect of Music Therapy on Pain Perception, Anxiety, and Opioid Use During Dressing Change Among Patients With Burns in India: A Quasi-experimental, Cross-over Pilot Study. Ostomy Wound Manage. 2018 Oct;64(10):40-46.
- Background: PubMed 24767806Rafii F, Mohammadi-Fakhar F, Jamshidi Orak R. Effectiveness of jaw relaxation for burn dressing pain: randomized clinical trial. Pain Manag Nurs. 2014 Dec;15(4):845-53. doi: 10.1016/j.pmn.2013.11.001. Epub 2014 Apr 24.
- Individual participant dataSharing planned: No. The work is still underway and is being monitored by a committee. It is also a doctoral thesis. Necessary comments will be received and then shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflexology massage and Reflexology massage and passive music in people with Burn Degree Second and Burn Degree Third, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 13 inclusion and 1 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 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 (time frame: 4 days). 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?
On the ClinicalTrials.gov record for NCT04200053, which also lists 3 linked publications.
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 26 Apr 2022.