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

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01590524
• Other study ID #: AC-GIPMRL-87
• Status: Completed
• Phase: N/A
• First received: February 8, 2012
• Last updated: October 7, 2014
• Start date: April 2012
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Cyprus University of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cyprus: Cyprus Bio-Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety
• Coping
• Mood
• Stress

Intervention

Behavioral:
• Guided Imagery and Progressive Muscle Relaxation
Daily implementation of the guided imagery and progressive muscle relaxation techniques additionally to weekly supervised sessions.

Locations

Country	Name	City	State
Cyprus	Archbishob Makarios Hospital	Nicosia

Sponsors (1)

Lead Sponsor	Collaborator
Cyprus University of Technology

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the number of Participants with anxiety	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	No
Secondary	Changes in the number of Participants with mood changes	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	No
Secondary	stress level with Biodots		1 week, 2 week, 3 week, 4 week	No