Diabetes Mellitus, Insulin-DependentNCT01567254
The Effect of Guided Imagery in Children With Type 1 Diabetes Mellitus on Glucose Levels and on Glycemic Control
A study testing guided imaginary and music ONLY in people with Diabetes Mellitus, Insulin-Dependent, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Diabetes Mellitus, Insulin-Dependent
- What is being tested?
- guided imaginary and music ONLY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2012to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Children with cognitive impairment which prevents them from using guided imagery
- Unable to understand Hebrew
- Hearing defect
- Attention deficit disorder
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
Read the 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.
- Visit no. 1:
- Will be arranged on date of their regular clinic visit
- Guidance to disk usage
- Biofeedback for autonomic parameters assessment
- Participants will be connected to the continuous glucose monitoring system (A system which the patient is blinded to glucose readings).
- Participants and parents will fill QOL questionnaire [The Diabetes Treatment Satisfaction Questionnaire (DTSQ) by Bradley C. et Al (16)], if not filled before.
- Participants will listen to disk for the first time in clinic, alone in a room with the parent
- At this stage participants will be aware of the group they are in (treatment vs. control), but team is still unaware.
- 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.
- 5th day visit:
- Participants will listen to disk for the last times in clinic, alone in a room.
- 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:
- Will be arranged on date of their regular clinic visit (12-14 weeks after visit no. 1)
- Biofeedback for autonomic parameters assessment
- Participants and parents will fill QOL questionnaires (The Diabetes Treatment Satisfaction Questionnaire (DTSQ) by Bradley C. et Al (16)
- 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.
- Conditions
- Diabetes Mellitus, Insulin-Dependent
- Being tested
- guided imaginary, music ONLY
- Keywords
- guided imaginary
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guided imaginaryBehavioural
Also called N\A
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 ONLYBehavioural
Also called N\A
music. It will be equal in length to the auditory guided imagery disk
| Study group | Role | What they receive |
|---|---|---|
| guided imaginary | Experimental | 7 children receiving auditory guided imagery disk Receives: Behavioral: guided imaginary |
| music | Active comparator | 6 children receiving music disk Receives: Behavioral: music ONLY |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Average of deltas of HA1C between before and after three months of peridic listening to auditory guided imagery, compared to listening to music.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Insulin-DependentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Assaf Harofeh MC, Assaf-Harofeh Medical Center
- Investigators
- Mariana Rachmiel, MD, Principal investigator, Hassaf Haroffeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567254
- Sponsor's protocol ID
- 54/11
- Status last verified
- Jan 2015
- First submitted
- 1 Feb 2012
- Last updated
- 5 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01567254
- Acronym / sponsor ID
- 54/11
- Conditions
- Diabetes Mellitus, Insulin-Dependent
- Keywords
- guided imaginary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Apr 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 30 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Visit no. 1:
- Will be arranged on date of their regular clinic visit
- Guidance to disk usage
- Biofeedback for autonomic parameters assessment
- Participants will be connected to the continuous glucose monitoring system (A system which the patient is blinded to glucose readings).
- Participants and parents will fill QOL questionnaire [The Diabetes Treatment Satisfaction Questionnaire (DTSQ) by Bradley C. et Al (16)], if not filled before.
- Participants will listen to disk for the first time in clinic, alone in a room with the parent
- At this stage participants will be aware of the group they are in (treatment vs. control), but team is still unaware.
- 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.
- 5th day visit:
- Participants will listen to disk for the last times in clinic, alone in a room.
- 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:
- Will be arranged on date of their regular clinic visit (12-14 weeks after visit no. 1)
- Biofeedback for autonomic parameters assessment
- Participants and parents will fill QOL questionnaires (The Diabetes Treatment Satisfaction Questionnaire (DTSQ) by Bradley C. et Al (16)
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| guided imaginary | Experimental | Behavioral: guided imaginary7 children receiving auditory guided imagery disk |
| music | Active comparator | Behavioral: music ONLY6 children receiving music disk |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Children with cognitive impairment which prevents them from using guided imagery
- Unable to understand Hebrew
- Hearing defect
- Attention deficit disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| guided imaginaryAlso: N\AAuditory 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. | Behavioural | guided imaginary |
| music ONLYAlso: N\Amusic. It will be equal in length to the auditory guided imagery disk | Behavioural | music |
Primary outcome
Blood glucose values before and after listening to the recording.
Time frame: 1 week
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 secondary outcome
The delta of HA1C between before and after three months of periodic listening to auditory guided imagery, compared to listening to music.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariana Rachmiel, MD principal investigator
Hassaf Haroffeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing guided imaginary and music ONLY in people with Diabetes Mellitus, Insulin-Dependent, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose values before and after listening to the recording. (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2015.