The time-related information about a nocebo treatment can modify its onset of action but not the heart rate variability

Temporal expectation can modulate the onset of nocebo hyperalgesia but not the heart rate variability: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN96623027

Enrollment

Registered

2020-09-22

Start date

2020-06-30

Completion date

Unknown

Last updated

2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nocebo modulation Not Applicable

Interventions

Randomization 1:1 allocation ratio, computer-generated random numbers lists with simple randomisation In order to test the nocebo temporal onset, participants perform the cold pressor test (CPT), wh

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy volunteers recruited from the student population of the VUB and through different social media outlets 2. Aged between 18 and 45 years old

Exclusion criteria

Exclusion criteria: Participants that were in cure with antidepressants or anxiolytics, had a history of cardiovascular disease and suffered from psychiatric, neurological, chronic musculoskeletal and pain-related disorders were not considered eligible to participate in the study. Moreover, we instructed the participants not to consume alcohol, caffeine-based drinks or supplements and analgesic medications twelve hours before the experiment.

Design outcomes

Primary

Measure	Time frame
The resistance time to the cold pressor test (CPT) measured using a stopwatch at baseline, CPT after 10 minutes, CPT after 35 minutes. The difference in percentage change of pain tolerance time is calculated as described below: ?10 = (CPT Test 10’100)/Baseline CPT-100 ?35 = (CPT Test 35’100)/Baseline CPT-100	—

Secondary

Measure	Time frame
1. Heart rate variability measured using the Polar V800 (Polar Electro Oy, Kempele, Finland) for 4 minutes at the beginning of the trial, 1 minute before each CPT performance and 2 minutes after each CPT performance 2. Level of anxiety measured using the Beck Anxiety Inventory (BAI) between the familiarisation phase with the CPT and the other test sessions 3. Motivational systems measured using the Behavioural Avoidance/Inhibition Scale (BIS/BAS) between the familiarisation phase with the CPT and the other test sessions 4. Fear of pain measured using the Fear of Pain Questionnaire (FAI) between the familiarisation phase with the CPT and the other test sessions 5. Degree of optimism measured using the Revised Life Oriented Test (LOT-R) between the familiarisation phase with the CPT and the other test sessions	—

Measure

Time frame

1. Heart rate variability measured using the Polar V800 (Polar Electro Oy, Kempele, Finland) for 4 minutes at the beginning of the trial, 1 minute before each CPT performance and 2 minutes after each CPT performance 2. Level of anxiety measured using the Beck Anxiety Inventory (BAI) between the familiarisation phase with the CPT and the other test sessions 3. Motivational systems measured using the Behavioural Avoidance/Inhibition Scale (BIS/BAS) between the familiarisation phase with the CPT and the other test sessions 4. Fear of pain measured using the Fear of Pain Questionnaire (FAI) between the familiarisation phase with the CPT and the other test sessions 5. Degree of optimism measured using the Revised Life Oriented Test (LOT-R) between the familiarisation phase with the CPT and the other test sessions

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Countries

Belgium

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026