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出境医 / 临床实验 / The Effectiveness of a Relaxation Technique on the Quality of Life and Symptoms in People Living With HIV

The Effectiveness of a Relaxation Technique on the Quality of Life and Symptoms in People Living With HIV

Study Description
Brief Summary:
Quality of life of people living with HIV is strongly affected by the presence of one or more symptoms, such as sleep problems, fatigue, muscle pain, anxiety and depressive symptoms. Autogenic training has shown positive effects on these symptoms in different populations, but there is very little evidence on the effects of this relaxation technique in people living with HIV.

Condition or disease Intervention/treatment Phase
HIV Other: autogenic training Not Applicable

Detailed Description:
The aim of this project is to evaluate the effectiveness of a relaxation technique, autogenic training, on the quality of life and the physical and psychological symptoms in people living with HIV.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effectiveness of a Relaxation Technique on the Quality of Life and Symptoms in People Living With HIV
Actual Study Start Date : April 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : December 2018
Arms and Interventions
Arm Intervention/treatment
Experimental: autogenic training
Autogenic training
 Other: autogenic training
autogenic training
Experimental: wait list
usual care for 6 months Autogenic training after 6 months
 Other: autogenic training
autogenic training
Outcome Measures
Primary Outcome Measures :
  1. Patient-Reported Outcomes Quality of Life-human immunodeficiency virus (PROQOL-HIV) [ Time Frame: 3 and 6 months ]
    The PROQOL-HIV questionnaire is composed of 43 Likert-type items (5-point scale ranging from 0=never to 4=always), including 39 items targeting 8 domains of HRQL and general health: physical health and symptoms (9 items), treatment impact (10 items), emotional distress (4 items), health concerns (4 items), body change (4 items), intimate relationships (3 items), social relationships (2 items), and stigma (2 items). Four extra items dealing with religious beliefs, finance, having children, and satisfaction with care are not part of the scoring scheme, but are used to gather additional information from the respondent. Responses to items will be totaled for each dimension and standardized on a scale from 0 to 100 points, in which higher values indicate a better health state.


Secondary Outcome Measures :
  1. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 3 and 6 months ]
    Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality and quantity. The19-item self-report questionnaire yields 7 component scores: subjective sleep quality, sleep latency, duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction each weighted equally on a 0-3 scale. The seven component scores are then summed to yield a global PSQI score, which has a range of 0-21; higher scores indicate worse sleep quality.

  2. Fatigue Severity Scale (FSS) [ Time Frame: 3 and 6 months ]
    Fatigue severity scale (FSS) is a 9-items instrument with seven items related to fatigue interference, one item related to the experience of fatigue itself and one item about what causes fatigue. Each item is scored on a 7-point Likert scale ranging from 1 (''strongly disagree'') to 7 (''strongly agree''). The mean score of the 9 items is used to estimate fatigue severity.

  3. Brief Pain Inventory [ Time Frame: 3 and 6 months ]
    Brief Pain Inventory (BPI) is a two-factor instrument that measures pain severity and pain interference. The pain severity factor has four items, all rated on a 0 ''No pain'' to 10 ''Pain as bad as you can imagine'' Likert scale. The pain interference factor has seven items, all rated on a 0 ''Does not interfere'' to 10 ''Interferes completely'' Likert scale. Arithmetic mean of the four severity items can be used as measures of pain severity; the arithmetic mean of the seven interference items can be used as a measure of pain interference

  4. State -Trait Anxiety Inventory (STAI) [ Time Frame: 3 and 6 months ]
    State-Trait Anxiety Inventory (STAI) is a 40-items instrument that measures state anxiety and trait anxiety. Each type of anxiety has its own scale of 20 different questions that are scored on a 4-point Likert scale ranging from 1 "Almost never" to 4 "Almost always". Scores range from 20 to 80, with higher scores correlating with greater anxiety.

  5. PHQ-9 [ Time Frame: 3 and 6 months ]
    Patient Health Questionnaire (PHQ-9) is a 9-item instrument that measure depressive symptoms severity. PhQ-9 score ranges from 0 to 27, because each of the 9 items can be scores from 0 "not at all" to 3 "nearly every day". Higher scores indicate higher severity.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Being older than 18 ;
  • have a diagnosis of HIV;
  • present at least one of the following symptoms during the preceding two weeks: sleep problems, fatigue, pain, anxiety or symptoms of depression;
  • understand and speak French and;
  • be able to follow the instructions to learn the relaxation technique.

Exclusion Criteria:

-

Contacts and Locations

Locations
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Canada, Quebec
CHUM
Montréal, Quebec, Canada, H2W1T8
CUSM
Montréal, Quebec, Canada, H4A3J1
Sponsors and Collaborators
Université de Montréal
Fonds de la Recherche en Santé du Québec
Investigators
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Principal Investigator: Pilar Ramirez-Garcia, PhD Université de Montréal
Tracking Information
First Submitted Date  ICMJE April 18, 2019
First Posted Date  ICMJE April 23, 2019
Last Update Posted Date September 11, 2019
Actual Study Start Date  ICMJE April 2015
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2019) 		Patient-Reported Outcomes Quality of Life-human immunodeficiency virus (PROQOL-HIV) [ Time Frame: 3 and 6 months ]
The PROQOL-HIV questionnaire is composed of 43 Likert-type items (5-point scale ranging from 0=never to 4=always), including 39 items targeting 8 domains of HRQL and general health: physical health and symptoms (9 items), treatment impact (10 items), emotional distress (4 items), health concerns (4 items), body change (4 items), intimate relationships (3 items), social relationships (2 items), and stigma (2 items). Four extra items dealing with religious beliefs, finance, having children, and satisfaction with care are not part of the scoring scheme, but are used to gather additional information from the respondent. Responses to items will be totaled for each dimension and standardized on a scale from 0 to 100 points, in which higher values indicate a better health state.
Original Primary Outcome Measures  ICMJE
 (submitted: April 22, 2019) 		PROQOL-HIV questionnaire [ Time Frame: 3 and 6 months ]
Reported quality of life
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2019)
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 3 and 6 months ]
    Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality and quantity. The19-item self-report questionnaire yields 7 component scores: subjective sleep quality, sleep latency, duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction each weighted equally on a 0-3 scale. The seven component scores are then summed to yield a global PSQI score, which has a range of 0-21; higher scores indicate worse sleep quality.
  • Fatigue Severity Scale (FSS) [ Time Frame: 3 and 6 months ]
    Fatigue severity scale (FSS) is a 9-items instrument with seven items related to fatigue interference, one item related to the experience of fatigue itself and one item about what causes fatigue. Each item is scored on a 7-point Likert scale ranging from 1 (''strongly disagree'') to 7 (''strongly agree''). The mean score of the 9 items is used to estimate fatigue severity.
  • Brief Pain Inventory [ Time Frame: 3 and 6 months ]
    Brief Pain Inventory (BPI) is a two-factor instrument that measures pain severity and pain interference. The pain severity factor has four items, all rated on a 0 ''No pain'' to 10 ''Pain as bad as you can imagine'' Likert scale. The pain interference factor has seven items, all rated on a 0 ''Does not interfere'' to 10 ''Interferes completely'' Likert scale. Arithmetic mean of the four severity items can be used as measures of pain severity; the arithmetic mean of the seven interference items can be used as a measure of pain interference
  • State -Trait Anxiety Inventory (STAI) [ Time Frame: 3 and 6 months ]
    State-Trait Anxiety Inventory (STAI) is a 40-items instrument that measures state anxiety and trait anxiety. Each type of anxiety has its own scale of 20 different questions that are scored on a 4-point Likert scale ranging from 1 "Almost never" to 4 "Almost always". Scores range from 20 to 80, with higher scores correlating with greater anxiety.
  • PHQ-9 [ Time Frame: 3 and 6 months ]
    Patient Health Questionnaire (PHQ-9) is a 9-item instrument that measure depressive symptoms severity. PhQ-9 score ranges from 0 to 27, because each of the 9 items can be scores from 0 "not at all" to 3 "nearly every day". Higher scores indicate higher severity.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 3 and 6 months ]
    Reported quality and patterns of sleep
  • Fatigue Severity Scale (FSS) [ Time Frame: 3 and 6 months ]
    Reported fatigue
  • Brief Pain Inventory [ Time Frame: 3 and 6 months ]
    Reported pain
  • State -Trait Anxiety Inventory (STAI) [ Time Frame: 3 and 6 months ]
    Reported anxiety
  • PHQ-9 [ Time Frame: 3 and 6 months ]
    Reported depressive symptoms
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effectiveness of a Relaxation Technique on the Quality of Life and Symptoms in People Living With HIV
Official Title  ICMJE The Effectiveness of a Relaxation Technique on the Quality of Life and Symptoms in People Living With HIV
Brief Summary Quality of life of people living with HIV is strongly affected by the presence of one or more symptoms, such as sleep problems, fatigue, muscle pain, anxiety and depressive symptoms. Autogenic training has shown positive effects on these symptoms in different populations, but there is very little evidence on the effects of this relaxation technique in people living with HIV.
Detailed Description The aim of this project is to evaluate the effectiveness of a relaxation technique, autogenic training, on the quality of life and the physical and psychological symptoms in people living with HIV.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE HIV
Intervention  ICMJE Other: autogenic training
autogenic training
Study Arms  ICMJE
  • Experimental: autogenic training
    Autogenic training
    Intervention: Other: autogenic training
  • Experimental: wait list
    usual care for 6 months Autogenic training after 6 months
    Intervention: Other: autogenic training
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: April 22, 2019) 		62
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Being older than 18 ;
  • have a diagnosis of HIV;
  • present at least one of the following symptoms during the preceding two weeks: sleep problems, fatigue, pain, anxiety or symptoms of depression;
  • understand and speak French and;
  • be able to follow the instructions to learn the relaxation technique.

Exclusion Criteria:

-
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 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 Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03924921
Other Study ID Numbers  ICMJE 2016-5940:PRG
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Université de Montréal
Study Sponsor  ICMJE Université de Montréal
Collaborators  ICMJE Fonds de la Recherche en Santé du Québec
Investigators  ICMJE
Principal Investigator: Pilar Ramirez-Garcia, PhD Université de Montréal
PRS Account Université de Montréal
Verification Date April 2019

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

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