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

Sponsor

Cyprus University of Technology (Other)

Overall Status

Completed

CT.gov ID

NCT01590524

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Stress Mood Coping	Behavioral: Guided Imagery and Progressive Muscle Relaxation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (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

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Changes in the number of Participants with anxiety [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

Secondary Outcome Measures

Changes in the number of Participants with mood changes [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
stress level with Biodots [1 week, 2 week, 3 week, 4 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Archbishob Makarios Hospital	Nicosia		Cyprus	2012

Sponsors and Collaborators

Cyprus University of Technology

Investigators

Principal Investigator: Andreas Charalambous, PhD, Cyprus University of Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Andreas Charalambous, Lecturer-Researcher, Cyprus University of Technology

ClinicalTrials.gov Identifier:

NCT01590524

Other Study ID Numbers:

AC-GIPMRL-87

First Posted:

May 3, 2012

Last Update Posted:

Oct 8, 2014

Last Verified:

Oct 1, 2014

Keywords provided by Dr. Andreas Charalambous, Lecturer-Researcher, Cyprus University of Technology

Parent

childhood cancer

Complementary and Alternative

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Oct 8, 2014