HIV-positive DiagnosisNCT02535429
Massage Therapy for HIV-positive People : Effects on Anxiety, Depression, Hyperventilation and Quality of Life
A study testing massage in people with HIV-positive Diagnosis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Massage therapy during 1 month and evaluation of depression, hyperventilation, anxiety and quality of life Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HIV-positive Diagnosis
- What is being tested?
- massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2015to Jul 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-positive diagnosis
Who cannot join
- musculoskeletal disorders
Trial locations and contacts
1 site in 1 country.
About this study
Massage therapy during 1 month and evaluation of depression, hyperventilation, anxiety and quality of life
- Conditions
- HIV-positive Diagnosis
- Being tested
- massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massageOther
| Study group | Role | What they receive |
|---|---|---|
| massage | Experimental | massage Receives: Other: massage |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety measured by Hospital anxiety and depression scale
Measured: 5 minutes
Depression measured by Hospital anxiety and depression scale
Measured: 5 minutes
Hyperventilation measured by NIJMEGEN questionnaire
Measured: 5 minutes
quality of life measured by World Health Organization Quality of Life Questionnaire
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-positive DiagnosisStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535429
- Sponsor's protocol ID
- HIV massage
- Status last verified
- Aug 2016
- First submitted
- 25 Aug 2015
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Massage Therapy for HIV-positive People : Effects on Anxiety, Depression, Hyperventilation and Quality of Life
- ClinicalTrials.gov ID
- NCT02535429
- Acronym / sponsor ID
- HIV massage
- Conditions
- HIV-positive Diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 28 Aug 2015 (estimated)
- 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.
Massage therapy during 1 month and evaluation of depression, hyperventilation, anxiety and quality of life
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| massage | Experimental | Other: massagemassage |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HIV-positive diagnosis
Key exclusion criteria (1 listed)
- musculoskeletal disorders
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 |
|---|---|---|
| massage | Other | massage |
Primary outcome
Anxiety measured by Hospital anxiety and depression scale
Time frame: 5 minutes
Depression measured by Hospital anxiety and depression scale
Time frame: 5 minutes
Hyperventilation measured by NIJMEGEN questionnaire
Time frame: 5 minutes
quality of life measured by World Health Organization Quality of Life Questionnaire
Time frame: 10 minutes
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 12 Aug 2016.
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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 massage in people with HIV-positive Diagnosis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 1 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 12 Aug 2016. 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 Belgium. 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?
Anxiety measured by Hospital anxiety and depression scale (time frame: 5 minutes). The study lists 4 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 12 Aug 2016.