Feeding and Eating DisordersNCT05382702

Fear, Gastrointestinal Distress, and Interoception: Physiological and Psychological Mechanisms in Eating Disorders

A study testing Test meal description changed in people with Feeding and Eating Disorders, run by Ohio University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The proposed study tests fear, gut peptide response, and perceptions of fullness as causes of gastrointestinal distress and eating disorder maintenance. Read more about this study

Who is it for?: Ages 18 to 40 years, women only
Conditions the study is for: Feeding and Eating Disorders
What is being tested?: Test meal description changed
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 133 participants
Where: 1 siteUnited States
Study dates: 22 Apr 2022to 20 Mar 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 40 years
Women only
No healthy volunteers
Adult

Who may be able to join

female
DSM-5 eating disorder
score 16 or higher on the Clinical Impairment Assessment
experience nausea or stomachache after eating at least "sometimes"
18 to 40 years old
body mass index between 18.5 and 26.5 kg/m2

Who cannot join

medical conditions affect appetite or weight
Recent pregnancy or current breastfeeding
Dairy, strawberry or honey food allergy
Specific phobia, blood-injection-injury type

Trial locations and contacts

1 site in 1 country.

United States1 site

Ohio University
Athens, Ohio, 45701

Other trials in United States

About this study

The proposed study tests fear, gut peptide response, and perceptions of fullness as causes of gastrointestinal distress and eating disorder maintenance.

Conditions: Feeding and Eating Disorders
Being tested: Test meal description changed
Medical subject headings: Feeding and Eating Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Test meal description changedOther
Using a within-subjects crossover design, on two separate mornings participants will eat yogurt described as 'high fat' and 'low fat.' In actuality, the meals will not differ.

Study groups in NCT05382702
Study group	Role	What they receive
High Fat Yogurt - Low Fat Yogurt	Other	Participants will eat yogurt described as 'high fat' at Study Visit 2 and yogurt described as 'low fat' at Study Visit 3. Receives: Other: Test meal description changed
Low Fat Yogurt - High Fat Yogurt	Other	Participants will eat yogurt described as 'low fat' at Study Visit 2 and yogurt described as 'high fat' at Study Visit 3. Receives: Other: Test meal description changed

What is being measured

The primary outcome is the main question the study is designed to answer.

Subjective Rating of Fear
Area under the curve with respect to increase (AUCi) from the 10 minutes period prior to the meal until immediately after the meal will be used to characterize changes in Visual Analogue Scale ratings of momentary fear ranging from "Not at All (0)" to "Extreme (100)." AUCi was calculated as: (((Fear at -10 minutes)+ (Fear at 0 minutes))*10/2) + (((Fear at 0 Minutes)+(Fear at +10 minutes))*10/2) - (Fear at -10 minutes)*20. A more positive score indicates greater increases in fear over the pre to post meal period.
Measured: -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention
Difference in Average Skin Conductance
Skin conductance data will be collected in microsiemens using a Biopac Bionomadix EDA System during the period before and after the test meal. The difference in average microsiemens will be computed for each test meal using the following equation: (Average activity for the 10 minute meal period) - (average activity for the 10 minutes prior to the meal). A higher difference indicates increased physiological activation during the meal period relative to the pre-meal period.
Measured: -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention
Gastrointestinal Distress
Gastrointestinal distress will be the averaged visual analogue scale ratings of "Nausea" and "Stomach Ache" ranging from "Not At All (0)" to "Extreme (100)." Area under the curve with respect to increase (AUCi) from the 10 minutes period prior to the meal until immediately after the meal will be used to characterize changes gastrointestinal distress. AUCi was calculated as: (((Gastrointestinal distress at -10 minutes)+ (Gastrointestinal distress at 0 minutes))*10/2) + (((Gastrointestinal distress at 0 Minutes)+(Gastrointestinal distress at +10 minutes))*10/2) - (Gastrointestinal distress at -10 minutes)*20. A more positive score indicates greater increases in gastrointestinal distress over the pre to post meal period.
Measured: -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention
Cholecystokinin Response
Blood was drawn repeatedly. Cholecystokinin (CCK) values in plasma were quantified in ng/mL using a commercially available enzyme immunoassay (Phoenix Pharmaceuticals EK-069-02). Area under the curve with respect to increase (AUCi) was calculated from the time period immediately before the test meal to 90 minutes after the test meal. AUCi was calculated as: (((CCK at 0 Minutes)+( CCK at +10 minutes))*10/2) + (((CCK at 10 Minutes)+( CCK at +20 minutes))*10/2) + (((CCK at 20 Minutes)+( CCK at +30 minutes))*10/2) + (((CCK at 30 Minutes)+( CCK at +60 minutes))*30/2) + (((CCK at+ 60 Minutes)+( CCK at +90 minutes))*30/2) - (CCK at -10 minutes)*90. A more positive score indicates greater increases in CCK over the pre to post meal period.
Measured: 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention
Peptide YY Response
Blood was drawn repeatedly. Peptide YY (PYY) values in plasma were quantified in ng/mL using a commercially available enzyme immunoassay (Phoenix Pharmaceuticals EK-059-02). Area under the curve with respect to increase (AUCi) was calculated from the time period immediately before the test meal to 90 minutes after the test meal. AUCi was calculated as: (((PYY at 0 Minutes)+( PYY at +10 minutes))*10/2) + (((PYY at 10 Minutes)+(PYY at +20 minutes))*10/2) + (((PYY at 20 Minutes)+( PYY at +30 minutes))*10/2) + (((PYY at 30 Minutes)+( PYY at +60 minutes))*30/2) + (((PYY at+ 60 Minutes)+( PYY at +90 minutes))*30/2) - (PYY at -10 minutes)*90. A more positive score indicates greater increases in PYY over the pre to post meal period.
Measured: 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention
Subjective Rating of Fullness
Fullness will be the averaged visual analogue scale ratings of "full" and "satiated(satisfied)" ranging from "Not At All (0)" to "Extreme (100)." Area under the curve with respect to increase (AUCi) will be used to characterize changes in fullness from immediately before the test meal to 90 minutes after. AUCi was calculated as: (((Fullness at -10 minutes)+ (Fullness at 0 minutes))*10/2) + (((Fullness at 0 Minutes)+( Fullness at +10 minutes))*10/2) + (((Fullness at 10 Minutes)+( Fullness at +20 minutes))*10/2) + (((Fullness at 20 Minutes)+( Fullness at +30 minutes))*10/2) + (((Fullness at 30 Minutes)+( Fullness at +60 minutes))*30/2) + (((Fullness at 60 Minutes)+( Fullness at +90 minutes))*30/2) - (Fullness at -10 minutes)*100. A more positive score indicates greater increases in fullness over the pre to post meal period.
Measured: 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention
Urges to Restrict Food Intake
Visual analogue scales will assess momentary "urge to restrict" from "Not At All" (0) to "Extreme" (100). The 60 minute assessment will be used for the exploratory serial mediation model.
Measured: 60 minutes post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Apr 202220 Mar 2025

First posted19 May 2022
Study start22 Apr 2022
Primary completion20 Mar 2025
Study completion20 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Feeding and Eating DisordersStudies 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05382702
Sponsor's protocol ID: 21-F-14
Other IDs: R15MH128703
Status last verified: Jan 2025
First submitted: 11 May 2022
Last updated: 15 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data will be shared according to the NIMH Data Sharing Policy (NOT-MH-19-033), including being shared with the NIMH Data Archive.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
Enrolling by invitationPhase 3
A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder
Binge-Eating Disorder
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating

All Feeding and Eating Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fear, Gastrointestinal Distress, and Interoception: Physiological and Psychological Mechanisms in Eating Disorders
ClinicalTrials.gov ID: NCT05382702
Acronym / sponsor ID: 21-F-14
Conditions: Feeding and Eating Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: Ohio UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 22 Apr 2022 (actual)
Primary completion: 20 Mar 2025 (actual)
Study completion: 20 Mar 2025 (actual)
First posted: 19 May 2022 (actual)
Results: Posted 15 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The proposed study tests fear, gut peptide response, and perceptions of fullness as causes of gastrointestinal distress and eating disorder maintenance.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
High Fat Yogurt - Low Fat Yogurt	Other	Other: Test meal description changedParticipants will eat yogurt described as 'high fat' at Study Visit 2 and yogurt described as 'low fat' at Study Visit 3.
Low Fat Yogurt - High Fat Yogurt	Other	Other: Test meal description changedParticipants will eat yogurt described as 'low fat' at Study Visit 2 and yogurt described as 'high fat' at Study Visit 3.

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

female
DSM-5 eating disorder
score 16 or higher on the Clinical Impairment Assessment
experience nausea or stomachache after eating at least "sometimes"
18 to 40 years old

Key exclusion criteria (4 listed)

medical conditions affect appetite or weight
Recent pregnancy or current breastfeeding
Dairy, strawberry or honey food allergy
Specific phobia, blood-injection-injury type

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
Test meal description changedUsing a within-subjects crossover design, on two separate mornings participants will eat yogurt described as 'high fat' and 'low fat.' In actuality, the meals will not differ.	Other	High Fat Yogurt - Low Fat Yogurt, Low Fat Yogurt - High Fat Yogurt

Primary outcome

Subjective Rating of Fear
Time frame: -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention
Area under the curve with respect to increase (AUCi) from the 10 minutes period prior to the meal until immediately after the meal will be used to characterize changes in Visual Analogue Scale ratings of momentary fear ranging from "Not at All (0)" to "Extreme (100)." AUCi was calculated as: (((Fear at -10 minutes)+ (Fear at 0 minutes))*10/2) + (((Fear at 0 Minutes)+(Fear at +10 minutes))*10/2) - (Fear at -10 minutes)*20. A more positive score indicates greater increases in fear over the pre to post meal period.
Difference in Average Skin Conductance
Time frame: -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention
Skin conductance data will be collected in microsiemens using a Biopac Bionomadix EDA System during the period before and after the test meal. The difference in average microsiemens will be computed for each test meal using the following equation: (Average activity for the 10 minute meal period) - (average activity for the 10 minutes prior to the meal). A higher difference indicates increased physiological activation during the meal period relative to the pre-meal period.
Gastrointestinal Distress
Time frame: -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention
Gastrointestinal distress will be the averaged visual analogue scale ratings of "Nausea" and "Stomach Ache" ranging from "Not At All (0)" to "Extreme (100)." Area under the curve with respect to increase (AUCi) from the 10 minutes period prior to the meal until immediately after the meal will be used to characterize changes gastrointestinal distress. AUCi was calculated as: (((Gastrointestinal distress at -10 minutes)+ (Gastrointestinal distress at 0 minutes))*10/2) + (((Gastrointestinal distress at 0 Minutes)+(Gastrointestinal distress at +10 minutes))*10/2) - (Gastrointestinal distress at -10 minutes)*20. A more positive score indicates greater increases in gastrointestinal distress over the pre to post meal period.
Cholecystokinin Response
Time frame: 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention
Blood was drawn repeatedly. Cholecystokinin (CCK) values in plasma were quantified in ng/mL using a commercially available enzyme immunoassay (Phoenix Pharmaceuticals EK-069-02). Area under the curve with respect to increase (AUCi) was calculated from the time period immediately before the test meal to 90 minutes after the test meal. AUCi was calculated as: (((CCK at 0 Minutes)+( CCK at +10 minutes))*10/2) + (((CCK at 10 Minutes)+( CCK at +20 minutes))*10/2) + (((CCK at 20 Minutes)+( CCK at +30 minutes))*10/2) + (((CCK at 30 Minutes)+( CCK at +60 minutes))*30/2) + (((CCK at+ 60 Minutes)+( CCK at +90 minutes))*30/2) - (CCK at -10 minutes)*90. A more positive score indicates greater increases in CCK over the pre to post meal period.
Peptide YY Response
Time frame: 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention
Blood was drawn repeatedly. Peptide YY (PYY) values in plasma were quantified in ng/mL using a commercially available enzyme immunoassay (Phoenix Pharmaceuticals EK-059-02). Area under the curve with respect to increase (AUCi) was calculated from the time period immediately before the test meal to 90 minutes after the test meal. AUCi was calculated as: (((PYY at 0 Minutes)+( PYY at +10 minutes))*10/2) + (((PYY at 10 Minutes)+(PYY at +20 minutes))*10/2) + (((PYY at 20 Minutes)+( PYY at +30 minutes))*10/2) + (((PYY at 30 Minutes)+( PYY at +60 minutes))*30/2) + (((PYY at+ 60 Minutes)+( PYY at +90 minutes))*30/2) - (PYY at -10 minutes)*90. A more positive score indicates greater increases in PYY over the pre to post meal period.
Subjective Rating of Fullness
Time frame: 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention
Fullness will be the averaged visual analogue scale ratings of "full" and "satiated(satisfied)" ranging from "Not At All (0)" to "Extreme (100)." Area under the curve with respect to increase (AUCi) will be used to characterize changes in fullness from immediately before the test meal to 90 minutes after. AUCi was calculated as: (((Fullness at -10 minutes)+ (Fullness at 0 minutes))*10/2) + (((Fullness at 0 Minutes)+( Fullness at +10 minutes))*10/2) + (((Fullness at 10 Minutes)+( Fullness at +20 minutes))*10/2) + (((Fullness at 20 Minutes)+( Fullness at +30 minutes))*10/2) + (((Fullness at 30 Minutes)+( Fullness at +60 minutes))*30/2) + (((Fullness at 60 Minutes)+( Fullness at +90 minutes))*30/2) - (Fullness at -10 minutes)*100. A more positive score indicates greater increases in fullness over the pre to post meal period.
Urges to Restrict Food Intake
Time frame: 60 minutes post-intervention
Visual analogue scales will assess momentary "urge to restrict" from "Not At All" (0) to "Extreme" (100). The 60 minute assessment will be used for the exploratory serial mediation model.

Results and safety

Results posted to the registry on 15 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Fat Yogurt - Low Fat Yogurt	54	47
Low Fat Yogurt - High Fat Yogurt	45	40

Primary outcome: Subjective Rating of Fear

Time frame: -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention. Mean (Standard Deviation). Unit: units on scale*minutes

Measure	High Fat Yogurt - Low Fat Yogurt n = 36	Low Fat Yogurt - High Fat Yogurt n = 32
High Fat Condition Fear AUCi	-36.9444 (306.65774)	-23.9219 (237.37717)
Low Fat Condition Fear AUCi	-47.3611 (266.97642)	85.6250 (191.48296)

High Fat Yogurt - Low Fat Yogurt vs Low Fat Yogurt - High Fat Yogurt: p = .879, t-test, 2 sided

Population analysed: In total, 75 people completed both test meal visits. However, only 68 individuals are included in the analyses of fear. We excluded the data of one participant whose responses suggested she did not attend to item content and the data of 5 individuals who failed to eat at least 85% of the yogurt test meal at any visit. One participant's self report data was missing at the -10 minute mark and so AUCi could not be calculated.

Primary outcome: Difference in Average Skin Conductance

Time frame: -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention. Mean (Standard Deviation). Unit: Difference in average microseimens

Measure	High Fat Yogurt - Low Fat Yogurt n = 28	Low Fat Yogurt - High Fat Yogurt n = 24
High Fat Condition- Difference	.5076 (1.01102)	.4773 (1.09442)
Low Fat Condition Difference	1.0938 (1.28887)	.6715 (1.24430)

High Fat Yogurt - Low Fat Yogurt vs Low Fat Yogurt - High Fat Yogurt: p = .059, t-test, 2 sided

Population analysed: In total, 75 people completed both test meal visits. However, only 52 individuals are included in the analyses of skin conductance activity. We excluded the data of 5 individuals who failed to eat at least 85% of the yogurt test meal at any visit. 18 individuals had data excluded due to failure of EDA data collection (e.g., average activity under 1 microseimen at any point).

Primary outcome: Gastrointestinal Distress

Time frame: -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention. Mean (Standard Deviation). Unit: units on scale*minutes

Measure	High Fat Yogurt - Low Fat Yogurt n = 36	Low Fat Yogurt - High Fat Yogurt n = 32
High Fat Condition Gastrointestinal Distress AUCi	19.5694 (239.84132)	-2.0469 (233.24380)
Low Fat Condition Gastrointestinal Distress AUCi	-59.5417 (240.87553)	31.5078 (229.12739)

High Fat Yogurt - Low Fat Yogurt vs Low Fat Yogurt - High Fat Yogurt: p = .468, t-test, 2 sided

Primary outcome: Cholecystokinin Response

Time frame: 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention. Mean (Standard Deviation). Unit: ng*minute/mL

Measure	High Fat Yogurt - Low Fat Yogurt n = 24	Low Fat Yogurt - High Fat Yogurt n = 27
High Fat Condition CCK AUCi	.5147 (115.38843)	20.9534 (73.71224)
Low Fat Condition CCK AUCi	.3726 (87.71157)	5.2803 (80.74009)

High Fat Yogurt - Low Fat Yogurt vs Low Fat Yogurt - High Fat Yogurt: p = .616, t-test, 2 sided

Population analysed: In total, 75 people completed both test meal visits. However, only 51 individuals are included in the analyses of CCK. We excluded the data of 5 individuals who failed to eat at least 85% of the yogurt test meal at any visit. AUCi could not be calculated for three individuals who were missing at least 1 sample. Finally, 16 individuals did not have plasma samples collected due to difficulties placing an IV, an adverse reaction to IV placement, or limited nursing staff availability.

Adverse events

Time frame: From enrollment to end of Study Visit 3, up to 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Fat Yogurt	0 of 99 (0%)	8 of 83 (9.6%)	0 of 99
Low Fat Yogurt	0 of 99 (0%)	4 of 82 (4.9%)	0 of 99

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Data will be shared according to the NIMH Data Sharing Policy (NOT-MH-19-033), including being shared with the NIMH Data Archive.

Related trials for Feeding and Eating Disorders

Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
Enrolling by invitationPhase 3
A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder
Binge-Eating Disorder
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating

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.

Katherine J Forney, PhD principal investigator

Ohio University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Test meal description changed in people with Feeding and Eating Disorders, run by Ohio University at 1 site in United States.

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 6 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 15 Apr 2026. 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 United States. 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?

Yes. Results are posted in the registry (first posted 15 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Subjective Rating of Fear (time frame: -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05382702.

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 15 Apr 2026.