Guided Imagery & Music in Cancer
|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: NCT03936075|
Recruitment Status : Active, not recruiting
First Posted : May 3, 2019
Last Update Posted : July 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cancer, Breast Cancer, Metastatic Cancer Ovaries Cancer Uterus Cervix||Behavioral: the Guided Imagery and Music method Behavioral: standard care and verbal counselling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||two randomised groups, one intervention group and one placebo group|
|Masking:||Double (Participant, Care Provider)|
|Primary Purpose:||Supportive Care|
|Official Title:||Guided Imagery & Music in Active Treatment for Gynecologic or Breast Cancer: An RCT Pilot|
|Actual Study Start Date :||July 1, 2018|
|Actual Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||December 31, 2020|
treatment with the provision of 6 individual sessions of the Guided Imagery and Music method as a psychological supportive intervention, and psychometric questionnaires collection
Behavioral: the Guided Imagery and Music method
the method involves listening to the music while describing the experience to the therapist, any visual imagery that is evoked by the music, emotions, body sensations, thoughts or memories. after the music listening session, there is discussion upon making meaning of the experience and finding resources as potential coping skills
Other Name: receptive music psychotherapy
Placebo Comparator: control
standard care treatment with psychometric questionnaires collection and two individual counselling sessions, at baseline (week 1) and at the end (week 6)
Behavioral: standard care and verbal counselling
the participants receive their usual cancer treatment and two individual counselling sessions
- Profiles of Mood States (POMS) Brief version (adapted) [ Time Frame: Baseline and up to 12 weeks (post-intervention) ]Brief version adapted in Greek. A 30-item scale designed to assess six different moods namely tension, anger, vigor, fatigue, depression, confusion. It requires to indicate mood state over the last week, with a single word, each item ranging from 0(not at all) to 4 (extremely). The questionnaire is a sum of its 6 sub scales (each addressing the aforementioned moods), with a total score from 0 to 120. Lower scores indicate better mood states.
- Herth Hope Index [ Time Frame: Baseline and up to 12 weeks (post-intervention) ]A 12-item Likert-format instrument assessing current levels of hope from 1(strongly disagree) to 4 (strongly agree). It consists of three sub scales, examining interconnectedness, temporality and spirituality, and positiveness or expectancy. A higher score of the sum or the 3 sub scales indicates a higher hope level with scores ranging from 12 to 48.
- Cancer-related Fatigue Scale (CFS) [ Time Frame: Baseline and up to 12 weeks (post-intervention) ]An instrument consisting of 15 items that assess physical, affective, and cognitive dimensions of fatigue at present moment, with Likert scales ranging from 1 to 5. the physical sub scale consists of 7 items, the affective sub scale consists of 4 items, and the cognitive sub scale consists of 3 items and the total of all 3 sub scales indicate that greater scores correspond to greater fatigue levels.
- Visual Analogue Scale for Hope (VAS-H) [ Time Frame: obtained 6 times throughout the completion of intervention (up to 12 weeks) ]VAS is a single, frequent measurement to address the current levels of hope. Its s based on a 100cm horizontal line from 1cm (hopeless) to 100cm (hopeful)
- Visual Analogue Scale for Fatigue (VAS-F) [ Time Frame: Obtained 6 times throughout the completion of intervention (up to 12 weeks) ]VAS is a single, frequent measurement to address the current levels of fatigue.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936075
|Aretaieion University Hospital|
|Athens, Attiki, Greece, 11528|
|Study Director:||Niels Hannibal, PhD||Aalborg University|