Feasibility Study on the Effect of Complementary Methods as Supportive Interventions for Parents of Children With Cancer
Randomized Control Trial for the Effect of Guided Imagery and Progressive Muscle Relaxation in Reducing Anxiety for Parents of Hospitalized Children With Cancer
1 other identifier
interventional
52
1 country
1
Brief Summary
The purpose of this study is to determine whether Guided Imagery and Progressive Muscle relaxation are effective as stress reducing techniques in parents of hospitalized children with cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable anxiety
Started Apr 2012
Longer than P75 for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedFirst Posted
Study publicly available on registry
May 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedOctober 8, 2014
October 1, 2014
2.4 years
February 8, 2012
October 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in the number of Participants with anxiety
Participants response to the complementary and alternative intervention will be measured through their scores on the Hamilton Anxiety Scale
1 week, 2 week, 3 week , 4 week
Secondary Outcomes (2)
Changes in the number of Participants with mood changes
1 week, 2 week, 3 week , 4 week
stress level with Biodots
1 week, 2 week, 3 week, 4 week
Study Arms (2)
CAM group
EXPERIMENTALSubjects receiving the interventions and standard psychological care
No-CAM group
NO INTERVENTIONParents receiving only standard psychological care
Interventions
Daily implementation of the guided imagery and progressive muscle relaxation techniques additionally to weekly supervised sessions.
Eligibility Criteria
You may qualify if:
- willingness to participate
- having a child with childhood cancer been hospitalized for 4 weeks
- have a child (0-18) of age with childhood cancer
- able to speak and write Greek fluently
- no previous experience with CAM techniques
You may not qualify if:
- receiving drug therapy for stress
- using another CAM technique during the study
- parents of children receiving palliative care
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Archbishob Makarios Hospital
Nicosia, Nicosia, 2012, Cyprus
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas Charalambous, PhD
Cyprus University of Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer-Researcher
Study Record Dates
First Submitted
February 8, 2012
First Posted
May 3, 2012
Study Start
April 1, 2012
Primary Completion
September 1, 2014
Study Completion
October 1, 2014
Last Updated
October 8, 2014
Record last verified: 2014-10