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The Effect of Guided Imagery in Children With Type 1 Diabetes Mellitus on Glucose Levels and on Glycemic Control

NCT01567254 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2015-01-05

No results posted yet for this study

Summary

Background: Pediatric patients with type 1 diabetes mellitus are known to be a challenging group for achieving recommended glycemic control. Coping with the demands of self-managing IDDM in children and adolescents can be a formidable task, requiring a healthy and balanced diet, monitoring and regular insulin injections. Most patients are non-compliant to the treatment. A number of controlled studies have examined the efficiency of psychosocial interventions for improving compliance and glycemic control among diabetic youth. None has examined the effectiveness of guided imagery in treatment of type 1 diabetes mellitus.

Primary Objective: To asses simultaneously the effect of listening to auditory guided imagery and blood glucose variability, compared to variability in blood glucose while listening to songs.

Secondary Objective To assess the effect of routine auditory guided imagery to glycemic control and quality of life in children with type 1 diabetes mellitus, compared to listening listening to songs.

Methods:

Subjects: 14 youth ages 7-16 years with type 1 diabetes mellitus , for at least 6 months, and not during the honey moon period will be recruited, and will be blindly randomized to receive intervention (auditory guided imagery group) or control (regular auditory music).

Protocol:

Design: A randomized Controlled Blinded Study Intervention: 14 randomly numbered CD's will be prepared at study initiation, half containing auditory guided imagery and half containing music.

Study protocol: After an initial check up, including HbA1C levels, and explanation of study procedures the participants will be given either the intervention or the control CD, to be used twice a day for five days. During this period continuous glucose monitoring will be performed. On days one and five the procedure will take place while the participants are connected to biofeedback. QOL questionnaires will be completed at the beginning of day one, or before.

In the second part of the study the children will use the intervention / control CD at home twice a week for 12 weeks. At the end of the study period they will again be evaluated, including HbA1C, and all subjects will again complete QOL questionnaires

Conditions

  • Diabetes Mellitus, Insulin-Dependent

Interventions

BEHAVIORAL

guided imaginary

Auditory guided imagery disk - will be prepared by Ronit Brooks, a clinical psychologist, who is engaged in guided imagery and by Livia Yanai, an art therapist.

BEHAVIORAL

music ONLY

music. It will be equal in length to the auditory guided imagery disk

Sponsors & Collaborators

  • Assaf-Harofeh Medical Center

    lead OTHER_GOV

Principal Investigators

  • Mariana Rachmiel, MD · Hassaf Haroffeh Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01567254 on ClinicalTrials.gov