Feasibility Study on the Effect of Complementary Methods as Supportive Interventions for Parents of Children With Cancer
This study is currently recruiting participants.
Verified January 2013 by Cyprus University of Technology
Sponsor:
Cyprus University of Technology
Information provided by (Responsible Party):
Dr. Andreas Charalambous, Cyprus University of Technology
ClinicalTrials.gov Identifier:
NCT01590524
First received: February 8, 2012
Last updated: January 8, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Anxiety Stress Mood Coping |
Behavioral: Guided Imagery and Progressive Muscle Relaxation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Supportive Care |
| 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 |
Resource links provided by NLM:
Further study details as provided by Cyprus University of Technology:
Primary Outcome Measures:
- Changes in the number of Participants with anxiety [ Time Frame: 1 week, 2 week, 3 week , 4 week ] [ Designated as safety issue: No ]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 [ Time Frame: 1 week, 2 week, 3 week , 4 week ] [ Designated as safety issue: No ]Participants response to the complementary and alternative interventions will be measured through their scores on the POMS scale
- stress level with Biodots [ Time Frame: 1 week, 2 week, 3 week, 4 week ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CAM group
Subjects receiving the interventions and standard psychological care
|
Behavioral: Guided Imagery and Progressive Muscle Relaxation
Daily implementation of the guided imagery and progressive muscle relaxation techniques additionally to weekly supervised sessions.
|
|
No Intervention: No-CAM group
Parents receiving only standard psychological care
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01590524
Locations
| Cyprus | |
| Archbishob Makarios Hospital | Recruiting |
| Nicosia, Cyprus, 2012 | |
| Contact: Androulla Papavasileiou, Bsc Nursing 0035799748233 papavasi@cytanet.com.cy | |
| Principal Investigator: Theologia Tsitsi, MSc | |
Sponsors and Collaborators
Cyprus University of Technology
Investigators
| Principal Investigator: | Andreas Charalambous, PhD | Cyprus University of Technology |
More Information
No publications provided
| Responsible Party: | Dr. Andreas Charalambous, Lecturer-Researcher, Cyprus University of Technology |
| ClinicalTrials.gov Identifier: | NCT01590524 History of Changes |
| Other Study ID Numbers: | AC-GIPMRL-87 |
| Study First Received: | February 8, 2012 |
| Last Updated: | January 8, 2013 |
| Health Authority: | Cyprus: Cyprus Bio-Ethics Committee |
Keywords provided by Cyprus University of Technology:
|
Parent childhood cancer Complementary and Alternative |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013