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

NCT01567254 | Completed

• 1 other identifier: 54/11
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

guided imaginary

Outcome Measures

Primary Outcomes (1)

• Blood glucose values before and after listening to the recording.

  Blood glucose variability of teenagers before and after listening to auditory guided imagery, compared to the blood glucose variability of teenagers before and after listening to music. The blood glucose values will be measured by continuous glucose monitoring system (CGMS).

  1 week

Secondary Outcomes (1)

• The delta of HA1C between before and after three months of periodic listening to auditory guided imagery, compared to listening to music.

  3 months

Study Arms (2)

guided imaginary

EXPERIMENTAL

7 children receiving auditory guided imagery disk

Behavioral: guided imaginary

music

ACTIVE COMPARATOR

6 children receiving music disk

Behavioral: music ONLY

Interventions

guided imaginary BEHAVIORAL

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.

Also known as: N\A

guided imaginary

music ONLY BEHAVIORAL

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

Also known as: N\A

music

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Type 1 diabetes mellitus for longer than 6 months
• Insulin requirements of more than 0.4 units/kg/day for at least 3 months
• Age 7-16 years
• Agreement of parents or guardian to participate in the study
• Agreement and wiliness of child to participate in the study

You may not qualify if:

• Children with cognitive impairment which prevents them from using guided imagery
• Unable to understand Hebrew
• Hearing defect
• Attention deficit disorder

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Assaf Haroffeh Medical center

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Mariana Rachmiel, MD

  Hassaf Haroffeh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Marianna Rachmiel

Study Record Dates

• First Submitted: February 1, 2012
• First Posted: March 30, 2012
• Study Start: April 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: January 5, 2015

Record last verified: 2015-01

Locations

IL (1)