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

October 7, 2014 updated by: Dr. Andreas Charalambous, Cyprus University of Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cyprus
      • Nicosia, Cyprus, 2012
        • Archbishob Makarios Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the number of Participants with anxiety
Time Frame: 1 week, 2 week, 3 week , 4 week
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the number of Participants with mood changes
Time Frame: 1 week, 2 week, 3 week , 4 week
Participants response to the complementary and alternative interventions will be measured through their scores on the POMS scale
1 week, 2 week, 3 week , 4 week
stress level with Biodots
Time Frame: 1 week, 2 week, 3 week, 4 week
1 week, 2 week, 3 week, 4 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cyprus University of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

February 8, 2012

First Submitted That Met QC Criteria

May 2, 2012

First Posted (Estimate)

May 3, 2012

Study Record Updates

Last Update Posted (Estimate)

October 8, 2014

Last Update Submitted That Met QC Criteria

October 7, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-GIPMRL-87

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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