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

NCT ID: NCT02380339

Last Updated: 2019-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2019-12-31

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.

Conditions

Hypoglycemia; Type One Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Psych-Educational and Bio Feedback (BF_

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.

Group Type: ACTIVE_COMPARATOR

Psych-Educational and BF sessions

Intervention Type: BEHAVIORAL

Psych-Educational and BF sessions

Psych-Educational session and virtual reality (VR)

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.

Group Type: EXPERIMENTAL

Psych-Educational session and virtual reality

Intervention Type: BEHAVIORAL

Psych-Educational session and virtual reality

Interventions

Psych-Educational session and virtual reality

Psych-Educational session and virtual reality

Intervention Type: BEHAVIORAL

Psych-Educational and BF sessions

Psych-Educational and BF sessions

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, , Israel

Site Status: RECRUITING

Countries

Israel

Facility Contacts

Hadas Lemberg, PhD

Role: primary

Lhadas@HADASSAH.ORG.IL

972-6777111

Other Identifiers

0098-14-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id