Ignite Creation Date:
2024-05-06 @ 12:23 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01567254
Status:
COMPLETED
Last Update Posted:
2015-01-05
First Post:
2012-02-01
Brief Title:
The Effect of Guided Imagery in Children With Type 1 Diabetes Mellitus on Glucose Levels and on Glycemic Control
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Assaf-Harofeh Medical Center
Study Overview
Official Title:
Subject A Blinded Randomized Trial the Effect of Guided Imagery in Children With Type 1 Diabetes Mellitus on Glucose Levels and on Glycemic Control
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 CDs 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
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 CDs 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 order01-14
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None