The Effect of Guided Imagery in Children With Type 1 Diabetes Mellitus on Glucose Levels and on Glycemic Control
Condition: Diabetes Mellitus, Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

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
    

Detailed description: 
      14 participants will be assigned research numbers in a consecutive recruitment order.(01-14).

      14 auditory disks will be prepared ahead of study initiation, 7 with the guided imagery
      program and 7 with regular songs.

      All will look similar from the outside. The disks will be numbered 01-14. Disks numbering
      will be performed by an investigator who is not part of treatment team, without knowing which
      disk contains which content. So that the team and participants are blinded to the disk
      content at initiation.

      Children and parents will be aware of the type of auditory disk after initial auscultation at
      visit number 1.

      The team will continue to be blinded to type of disk until end of study. 3. All participants
      will be aware at study initiation that they may receive the auditory guided imagery disk or a
      regular songs / story auditory disk.

      4. Visit no. 1:

        1. Will be arranged on date of their regular clinic visit

        2. Guidance to disk usage

        3. Biofeedback for autonomic parameters assessment

        4. Participants will be connected to the continuous glucose monitoring system (A system
           which the patient is blinded to glucose readings).

        5. Participants and parents will fill QOL questionnaire [The Diabetes Treatment
           Satisfaction Questionnaire (DTSQ) by Bradley C. et Al (16)], if not filled before.

        6. Participants will listen to disk for the first time in clinic, alone in a room with the
           parent

        7. At this stage participants will be aware of the group they are in (treatment vs.
           control), but team is still unaware.

        8. Participants will be able to come with brothers and parents and recreational activity
           will be available at site for all for entertainment 5. Visit no. 2-5: 6. Participants
           will listen to disk twice a day for the next four days alone in a room in our clinic.
           They will be able to come with brothers and parents, and recreational activity will be
           available at site for all for entertainment.

           7. 5th day visit:

      a. Participants will listen to disk for the last times in clinic, alone in a room.

      b. Participants will be disconnected from CGMS c. Biofeedback for autonomic parameters
      assessment 8. Participants will listen to disk at least twice a week, for additional 11
      weeks, at their choice of time and day, and will record the specific time of listening on
      study chart 9. Visit no. 6:

        1. Will be arranged on date of their regular clinic visit (12-14 weeks after visit no. 1)

        2. Biofeedback for autonomic parameters assessment

        3. Participants and parents will fill QOL questionnaires (The Diabetes Treatment
           Satisfaction Questionnaire (DTSQ) by Bradley C. et Al (16)

        4. End of study 10. Data will be collected from charts from dates of visit no. 1 and visit
           no. 3 regarding: weight, height, BMI, 14 days average blood glucose levels, HbA1c.
    

Intervention name(s): guided imaginary; music ONLY
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; music. It will be equal in length to the auditory guided imagery disk
Other intervention name(s): N\A; N\A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: guided imaginary