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Massage Therapy for HIV-positive People : Effects on Anxiety, Depression, Hyperventilation and Quality of Life

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02535429
Recruitment Status : Completed
First Posted : August 28, 2015
Last Update Posted : August 12, 2016
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Tracking Information
First Submitted Date  ICMJE August 25, 2015
First Posted Date  ICMJE August 28, 2015
Last Update Posted Date August 12, 2016
Study Start Date  ICMJE July 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2015)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Massage Therapy for HIV-positive People : Effects on Anxiety, Depression, Hyperventilation and Quality of Life
Official Title  ICMJE Not Provided
Brief Summary Massage therapy during 1 month and evaluation of depression, hyperventilation, anxiety and quality of life
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE HIV-positive Diagnosis
Intervention  ICMJE Other: massage
Study Arms  ICMJE
  • Experimental: massage
    massage
    Intervention: Other: massage
  • No Intervention: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2016)
28
Original Estimated Enrollment  ICMJE
 (submitted: August 27, 2015)
50
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HIV-positive diagnosis

Exclusion Criteria:

  • musculoskeletal disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02535429
Other Study ID Numbers  ICMJE HIV massage
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Sponsor  ICMJE Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP