Back to resultsFeasibility Study on the Effect of Complementary Methods as Supportive Interventions for Parents of Children With Cancer
Primary Purpose
Anxiety, Stress, Mood
Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Guided Imagery and Progressive Muscle Relaxation
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety focused on measuring Parent, childhood cancer, Complementary and Alternative
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- receiving drug therapy for stress
using another CAM technique during the study
- parents of children receiving palliative care
Sites / Locations
- Archbishob Makarios Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CAM group
No-CAM group
Arm Description
Subjects receiving the interventions and standard psychological care
Parents receiving only standard psychological care
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Changes in the number of Participants with mood changes
Participants response to the complementary and alternative interventions will be measured through their scores on the POMS scale
stress level with Biodots
Full Information
NCT ID
NCT01590524
First Posted
February 8, 2012
Last Updated
October 7, 2014
Sponsor
Cyprus University of Technology
1. Study Identification
Unique Protocol Identification Number
NCT01590524
Brief Title
Feasibility Study on the Effect of Complementary Methods as Supportive Interventions for Parents of Children With Cancer
Official Title
Randomized Control Trial for the Effect of Guided Imagery and Progressive Muscle Relaxation in Reducing Anxiety for Parents of Hospitalized Children With Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cyprus University of Technology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Having a children with cancer can be a source of stress for parents during hospitalization. The stress experienced by the parents can negatively influence their functionality, daily activities, psychological state and also their physical condition. The studies in the literature have mainly focused on the child rather than the parent, and studies specifically for guided imagery are scarce. Since the parents are often neglected by the healthcare professionals during the stress evoking period of hospitalization, this study will test the effectiveness of complementary methods in improving the psychological state of the parents.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Stress, Mood, Coping
Keywords
Parent, childhood cancer, Complementary and Alternative
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAM group
Arm Type
Experimental
Arm Description
Subjects receiving the interventions and standard psychological care
Arm Title
No-CAM group
Arm Type
No Intervention
Arm Description
Parents receiving only standard psychological care
Intervention Type
Behavioral
Intervention Name(s)
Guided Imagery and Progressive Muscle Relaxation
Intervention Description
Daily implementation of the guided imagery and progressive muscle relaxation techniques additionally to weekly supervised sessions.
Primary Outcome Measure Information:
Title
Changes in the number of Participants with anxiety
Description
Participants response to the complementary and alternative intervention will be measured through their scores on the Hamilton Anxiety Scale
Time Frame
1 week, 2 week, 3 week , 4 week
Secondary Outcome Measure Information:
Title
Changes in the number of Participants with mood changes
Description
Participants response to the complementary and alternative interventions will be measured through their scores on the POMS scale
Time Frame
1 week, 2 week, 3 week , 4 week
Title
stress level with Biodots
Time Frame
1 week, 2 week, 3 week, 4 week
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
receiving drug therapy for stress
using another CAM technique during the study
parents of children receiving palliative care
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Charalambous, PhD
Organizational Affiliation
Cyprus University of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Archbishob Makarios Hospital
City
Nicosia
ZIP/Postal Code
2012
Country
Cyprus
12. IPD Sharing Statement
Learn more about this trial
Feasibility Study on the Effect of Complementary Methods as Supportive Interventions for Parents of Children With Cancer
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