Reducing Nocebo Effects on Pressure Pain

NACompletedINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

March 23, 2021

Primary Completion Date

April 5, 2022

Study Completion Date

April 5, 2022

Conditions
PainHyperalgesia
Interventions
BEHAVIORAL

Closed-label nocebo conditioning

"Conditioning consists of a learning and test phase. In the learning phase, a message indicating the sham activation of a Transcutaneous Electrical Nerve Stimulation (TENS) device (CS) will be repeatedly paired with a moderate intensity pressure pain stimulus, whereas a message indicating the deactivation of the sham device will be repeatedly paired with a slightly painful pressure pain stimulus. Participants will be given a verbal suggestion in line with the conditioning procedure (i.e. activation of the device will increase their pain). The testing phase is similar to the learning phase, but a slight pressure pain intensity is used for all trials, to test for a nocebo effect (i.e. to test whether participants score TENS on trials as more painful than TENS off trials)."

BEHAVIORAL

Closed-label counterconditioning

"Counterconditioning consists of a learning and test phase. In the learning phase, a message indicating the sham activation of the TENS device (CS) is now repeatedly paired with a non-painful intensity pressure pain stimulus, whereas a message indicating the sham deactivation of the TENS device will be repeatedly paired with a slightly painful pressure pain stimulus. Participants will be given a verbal suggestion in line with the counterconditioning procedure (i.e. activation of the device will reduce their pain). The testing phase is similar to the learning phase, but a slight pressure pain intensity is used for all trials, to test whether the nocebo effect is successfully reduced (i.e. to test whether participants no longer score TENS on trials as more painful than TENS off trials or even score TENS on trials as less painful)."

BEHAVIORAL

Open-label counterconditioning

"Counterconditioning consists of a learning and test phase. In the learning phase, a message indicating the sham activation of the TENS device (CS) is now repeatedly paired with a non-painful intensity pressure pain stimulus, whereas a message indicating the sham deactivation of the TENS device will be repeatedly paired with a slightly painful pressure pain stimulus. Participants will be given a open-label verbal suggestions in line with the counterconditioning procedure (i.e. they are told counterconditioning will be used to reduce nocebo effects and they are told the device is sham, but that their pain will still be influenced because of the placebo effect). The testing phase is similar to the learning phase, but a slight pressure pain intensity is used for all trials, to test whether the nocebo effect is successfully reduced (i.e. to test whether participants no longer score TENS on trials as more painful than TENS off trials or even score TENS on trials as less painful)."

BEHAVIORAL

Closed-label extinction

"Extinction consists of a learning and test phase. In the learning phase, slightly painful stimuli are used for all trials. During the testing phase, again a slight pressure pain intensity is used for all trials, to test whether the nocebo effect is successfully reduced (i.e. to test whether participants no longer score TENS on trials as more painful than TENS off trials)."

Trial Locations (1)

2333AK

Leiden University, Leiden

All Listed Sponsors
lead

Leiden University

OTHER

NCT05284383 - Reducing Nocebo Effects on Pressure Pain | Biotech Hunter | Biotech Hunter