Trial Outcomes & Findings for Human Behaviors Related to the Expectation of Pain (NCT NCT03739645)

Last Updated: 2025-05-25

Results Overview

Concrete metric is skin conductance response to painful laser pulse stimulus measured in microSiemens. Higher values mean more emotional arousal or stress. All participants experienced two types of conditioned stimuli, one stimulus signaled danger and the other safety. Only during the danger stimulus would the participant receive a laser pulse.

Recruitment status

TERMINATED

Study phase

Target enrollment

32 participants

Primary outcome timeframe

5 seconds post conditioned stimulus

Results posted on

2025-05-25

Participant Flow

A total of 32 participants were consented. 1 participant didn't meet criteria and was not randomized.

Participant milestones

Participant milestones
Measure	Eye Position and Tense Arousal Over Time a Metrics for Sustained Attention in Conditioned Fear. Skin conductance levels and slopes over time in conditioned fear as metrics.as metrics for anxiety: After fear conditioning the cue induces autonomic responses like skin conductance and cognitive ratings like expectancy of the unconditioned stimulus after cueing or conditioning. Activity across blocks in the conditioning stage shows that the skin conductance can be described by levels, and slopes which might be related to state anxiety and trait anxiety (Spielberger trait and state anxiety inventory or questionnaire). These skin conductance measures may be concrete metrics for psychological processes in healthy subjects. We will carry out a partial correlation analysis of levels, state anxiety and trait anxiety, and then a similar analysis of slopes, state anxiety and trait anxiety. These results may show that concrete skin conductance levels and slopes are related to metrics of subjective self report measures of state and trait anxiety.
Overall Study STARTED	31
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Human Behaviors Related to the Expectation of Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eye Position and Tense Arousal Over Time a Metrics for Sustained Attention in Conditioned Fear. n=31 Participants Skin conductance levels and slopes over time in conditioned fear as metrics.as metrics for anxiety: After fear conditioning the cue induces autonomic responses like skin conductance and cognitive ratings like expectancy of the unconditioned stimulus after cueing or conditioning. Activity across blocks in the conditioning stage shows that the skin conductance can be described by levels, and slopes which might be related to state anxiety and trait anxiety (Spielberger trait and state anxiety inventory or questionnaire). These skin conductance measures may be concrete metrics for psychological processes in healthy subjects. We will carry out a partial correlation analysis of levels, state anxiety and trait anxiety, and then a similar analysis of slopes, state anxiety and trait anxiety. These results may show that concrete skin conductance levels and slopes are related to metrics of subjective self report measures of state and trait anxiety.
Age, Continuous	26.8 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 seconds post conditioned stimulus

Outcome measures

Outcome measures
Measure	Eye Position and Tense Arousal Over Time a Metrics for Sustained Attention in Conditioned Fear. n=31 Participants Skin conductance levels and slopes over time in conditioned fear as metrics.as metrics for anxiety: After fear conditioning the cue induces autonomic responses like skin conductance and cognitive ratings like expectancy of the unconditioned stimulus after cueing or conditioning. Activity across blocks in the conditioning stage shows that the skin conductance can be described by levels, and slopes which might be related to state anxiety and trait anxiety (Spielberger trait and state anxiety inventory or questionnaire). These skin conductance measures may be concrete metrics for psychological processes in healthy subjects. We will carry out a partial correlation analysis of levels, state anxiety and trait anxiety, and then a similar analysis of slopes, state anxiety and trait anxiety. These results may show that concrete skin conductance levels and slopes are related to metrics of subjective self report measures of state and trait anxiety.
Skin Conductance Response Danger Stimulus	.19 micro Siemens Standard Error .037
Skin Conductance Response Safety Stimulus	.016 micro Siemens Standard Error .0068

PRIMARY outcome

Timeframe: Baseline, post conditioning up to 6 minutes

The Spielberger State-Trait Anxiety Inventory (STAI) is a 40-item self-report questionnaire with 20 items designed to assess State anxiety (temporary feelings of anxiety). The State anxiety score range is between 20 and 80 with higher scores representing higher anxiety. State anxiety was measured and is reported.

Outcome measures

Outcome measures
Measure	Eye Position and Tense Arousal Over Time a Metrics for Sustained Attention in Conditioned Fear. n=31 Participants Skin conductance levels and slopes over time in conditioned fear as metrics.as metrics for anxiety: After fear conditioning the cue induces autonomic responses like skin conductance and cognitive ratings like expectancy of the unconditioned stimulus after cueing or conditioning. Activity across blocks in the conditioning stage shows that the skin conductance can be described by levels, and slopes which might be related to state anxiety and trait anxiety (Spielberger trait and state anxiety inventory or questionnaire). These skin conductance measures may be concrete metrics for psychological processes in healthy subjects. We will carry out a partial correlation analysis of levels, state anxiety and trait anxiety, and then a similar analysis of slopes, state anxiety and trait anxiety. These results may show that concrete skin conductance levels and slopes are related to metrics of subjective self report measures of state and trait anxiety.
State Anxiety as Assessed by the Spielberger State-Trait Anxiety Inventory Baseline	36.28 score on a scale Standard Error 1.56
State Anxiety as Assessed by the Spielberger State-Trait Anxiety Inventory Post Conditioning	39.59 score on a scale Standard Error 2.22

PRIMARY outcome

Timeframe: Post conditioning approximately 6 minutes

Pain Rating for Unpleasantness on a scale of 0 - 10 where 10 is the worst imaginable. All participants experienced two types of conditioned stimuli, one stimulus signaled danger and the other safety. Only during the danger stimulus would the participant receive a laser pulse.

Outcome measures

Outcome measures
Measure	Eye Position and Tense Arousal Over Time a Metrics for Sustained Attention in Conditioned Fear. n=31 Participants Skin conductance levels and slopes over time in conditioned fear as metrics.as metrics for anxiety: After fear conditioning the cue induces autonomic responses like skin conductance and cognitive ratings like expectancy of the unconditioned stimulus after cueing or conditioning. Activity across blocks in the conditioning stage shows that the skin conductance can be described by levels, and slopes which might be related to state anxiety and trait anxiety (Spielberger trait and state anxiety inventory or questionnaire). These skin conductance measures may be concrete metrics for psychological processes in healthy subjects. We will carry out a partial correlation analysis of levels, state anxiety and trait anxiety, and then a similar analysis of slopes, state anxiety and trait anxiety. These results may show that concrete skin conductance levels and slopes are related to metrics of subjective self report measures of state and trait anxiety.
Experimental Pain as Assessed by a Pain Rating Scale Danger Stimulus	3.43 score on a scale Standard Error .59
Experimental Pain as Assessed by a Pain Rating Scale Safety Stimulus	.82 score on a scale Standard Error .27

Adverse Events

Eye Position and Tense Arousal Over Time a Metrics for Sustained Attention in Conditioned Fear.

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Eye Position and Tense Arousal Over Time a Metrics for Sustained Attention in Conditioned Fear. n=31 participants at risk Skin conductance levels and slopes over time in conditioned fear as metrics.as metrics for anxiety: After fear conditioning the cue induces autonomic responses like skin conductance and cognitive ratings like expectancy of the unconditioned stimulus after cueing or conditioning. Activity across blocks in the conditioning stage shows that the skin conductance can be described by levels, and slopes which might be related to state anxiety and trait anxiety (Spielberger trait and state anxiety inventory or questionnaire). These skin conductance measures may be concrete metrics for psychological processes in healthy subjects. We will carry out a partial correlation analysis of levels, state anxiety and trait anxiety, and then a similar analysis of slopes, state anxiety and trait anxiety. These results may show that concrete skin conductance levels and slopes are related to metrics of subjective self report measures of state and trait anxiety.
Skin and subcutaneous tissue disorders Burn	3.2% 1/31 • Number of events 1 • Up to 3 days

Additional Information

Fred Lenz

Johns Hopkins University

Phone: 443.287.1609

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place