Feasibility Study on the Effect of Complementary Methods as Supportive Interventions for Parents of Children With Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Cyprus University of Technology
Sponsor:
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

February 8, 2012
January 8, 2013
April 2012
May 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01590524 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Anxiety
  • Stress
  • Mood
  • Coping
Behavioral: Guided Imagery and Progressive Muscle Relaxation
Daily implementation of the guided imagery and progressive muscle relaxation techniques additionally to weekly supervised sessions.
  • Experimental: CAM group
    Subjects receiving the interventions and standard psychological care
    Intervention: Behavioral: Guided Imagery and Progressive Muscle Relaxation
  • No Intervention: No-CAM group
    Parents receiving only standard psychological care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Cyprus
 
NCT01590524
AC-GIPMRL-87
Yes
Dr. Andreas Charalambous, Cyprus University of Technology
Cyprus University of Technology
Not Provided
Principal Investigator: Andreas Charalambous, PhD Cyprus University of Technology
Cyprus University of Technology
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP