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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Andreas Charalambous, Cyprus University of Technology
ClinicalTrials.gov Identifier:
NCT01590524
First received: February 8, 2012
Last updated: October 7, 2014
Last verified: October 2014
  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 ]

Enrollment: 52
Study Start Date: April 2012
Study Completion Date: October 2014
Primary Completion Date: September 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590524

Locations
Cyprus
Archbishob Makarios Hospital
Nicosia, Cyprus, 2012
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: October 7, 2014
Health Authority: Cyprus: Cyprus Bio-Ethics Committee

Keywords provided by Cyprus University of Technology:
Parent
childhood cancer
Complementary and Alternative

ClinicalTrials.gov processed this record on November 20, 2014