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A Combined Biofeedback-virtual Reality System for Reduction of Fear of Hypoglycemia

Primary Purpose

Hypoglycemia, Type One Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Psych-Educational session and virtual reality
Psych-Educational and BF sessions
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypoglycemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 1 diabetic patient, male and females above the age of 18.
  • Patients with significant fear of hypoglycemia as indicated in the HFS-W (equals or greater than 3 on at least one of the item on the HFS-W ).

Exclusion Criteria:

Patient with severe hypoglycemia event in the last 6 months will be excluded. Patient with mental illness will be excluded

Sites / Locations

  • Hadassah Medical Organization, Jerusalem, IsraelRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Psych-Educational and Bio Feedback (BF_

Psych-Educational session and virtual reality (VR)

Arm Description

Participants in the control group will undergo Psych-Educational and BF sessions in which they will receive information about FOH and about ways of coping with FOH and BF training. More specifically, they will learn about factors associated with FOH, behavioral manifestations of FOH, negative consequences of these behavioral manifestations and about ways of coping with FOH. They will be instructed to practice BF for 15 minutes, at home for 5 initial training sessions during a week. After which they will receive another session of BF training and will be instructed to practice it at home for 10 sessions course, (5 weekly sessions for 2 weeks). Each session will be for 15 minutes.

Participants in the intervention group will receive Psych-Educational session as the control group and in addition they will participate in training for VR system and will be asked to use it at home for 5 initial training sessions during a week. During this week, they will practice reducing their GSR levels as indicated by the BF device. Following this they will receive a combined biofeedback-virtual reality system and use it at home for a 10 sessions course, (5 weekly sessions for 2 weeks). Each session will be for 15 minutes.

Outcomes

Primary Outcome Measures

Reduction of fear of hypoglycemia in type 1 diabetic patients as measured by reduction of 2 point on the HFS-W). pre-treatment and after two months post completion of treatment.

Secondary Outcome Measures

Full Information

First Posted
March 2, 2015
Last Updated
September 10, 2019
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT02380339
Brief Title
A Combined Biofeedback-virtual Reality System for Reduction of Fear of Hypoglycemia
Official Title
A Combined Biofeedback-virtual Reality System for Reduction of Fear of Hypoglycemia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Uncontrolled diabetes is associated with increased risk for micro-vascular complication. Hypoglycemia is one of the major barriers in achieving good glucose control. Hypoglycemia is associated with a range of unpleasant symptoms including palpitations, tremor, hunger, sweating, confusion, difficulties in thinking as well as other idiosyncratic symptoms. Fear of hypoglycemia (FOH) refers to phobic avoidance reactions associated with hypoglycemia FOH may increase behavioral attempts to avoid hypoglycemia including decreased consumption of insulin and/or increased consumption of carbohydrates, resulting in poor glycemic control and an increased risk of diabetic complication. In this study, the investigators present a novel system, which simultaneously employs BioFeedback and Virtual Reality in order to cope with fear of hypoglycemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia, Type One Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psych-Educational and Bio Feedback (BF_
Arm Type
Active Comparator
Arm Description
Participants in the control group will undergo Psych-Educational and BF sessions in which they will receive information about FOH and about ways of coping with FOH and BF training. More specifically, they will learn about factors associated with FOH, behavioral manifestations of FOH, negative consequences of these behavioral manifestations and about ways of coping with FOH. They will be instructed to practice BF for 15 minutes, at home for 5 initial training sessions during a week. After which they will receive another session of BF training and will be instructed to practice it at home for 10 sessions course, (5 weekly sessions for 2 weeks). Each session will be for 15 minutes.
Arm Title
Psych-Educational session and virtual reality (VR)
Arm Type
Experimental
Arm Description
Participants in the intervention group will receive Psych-Educational session as the control group and in addition they will participate in training for VR system and will be asked to use it at home for 5 initial training sessions during a week. During this week, they will practice reducing their GSR levels as indicated by the BF device. Following this they will receive a combined biofeedback-virtual reality system and use it at home for a 10 sessions course, (5 weekly sessions for 2 weeks). Each session will be for 15 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Psych-Educational session and virtual reality
Intervention Description
Psych-Educational session and virtual reality
Intervention Type
Behavioral
Intervention Name(s)
Psych-Educational and BF sessions
Intervention Description
Psych-Educational and BF sessions
Primary Outcome Measure Information:
Title
Reduction of fear of hypoglycemia in type 1 diabetic patients as measured by reduction of 2 point on the HFS-W). pre-treatment and after two months post completion of treatment.
Time Frame
two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 1 diabetic patient, male and females above the age of 18. Patients with significant fear of hypoglycemia as indicated in the HFS-W (equals or greater than 3 on at least one of the item on the HFS-W ). Exclusion Criteria: Patient with severe hypoglycemia event in the last 6 months will be excluded. Patient with mental illness will be excluded
Facility Information:
Facility Name
Hadassah Medical Organization, Jerusalem, Israel
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hadas Lemberg, PhD
Phone
972-6777111
Email
Lhadas@HADASSAH.ORG.IL

12. IPD Sharing Statement

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A Combined Biofeedback-virtual Reality System for Reduction of Fear of Hypoglycemia

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