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Completed

NCT Number: NCT03924921

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHUM, Montreal, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

autogenic training

Other

autogenic training

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Université de Montréal

Other

Collaborators

  • Fonds de la Recherche en Santé du Québec

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 23, 2019
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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