The Effects of Open-label Placebos on Acute Stress
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Auckland, New Zealand
About this trial
The goal of this study is to find out whether an open-label placebo nasal spray can reduce stress among individuals engaging in a high-stress canyon swing. The main questions the study aims to answer are: 1) Does an open-label placebo increase likelihood of participants completing another jump? 2) Does the placebo affect how long it takes participants to jump, reduce the reported stress levels before the jump 3) Does the placebo change how enjoyable participants find the jump?
Researchers will compare participants who receive an open-label placebo nasal spray (a spray that contains no active medication and is clearly described as a placebo) with participants who receive no treatment (control). The aim is to see whether the placebo nasal spray can increase likelihood of participants completing another jump, reduce reported stress and improve participants overall enjoyment of the jump.
Participants will:
* Complete a short questionnaire before they jump * Either self administer a placebo nasal spray (one spray in each nostril) right before stepping through the gate to jump, or receive no treatment (control). * Complete a short questionnaire after completing the jump * Whether they complete another jump will be noted
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Signed-up to complete the canyon swing
Aged 18 years and over
Able to speak and understand English
Comfortable being randomised to either the open-label placebo or no-treatment control condition
Disqualifiers
Under 18 years of age
Unable to speak or understand English
Unable to provide informed consent
Trial design
Design model
Parallel
Treatments tested in this trial
Open Label Placebo
Other interventionParticipants allocated to the placebo arm will self-administer the nasal spray before entering through the gate to jump. The nasal spray contains no active ingredients. It is made of a saline solution and is described to participants as a placebo. Participants are informed that placebos can produce powerful effects and have been shown to reduce stress and anxiety through expectations and prior learning - processes where the body learns to respond automatically to cues that are associated with a relief in symptoms.
Treatment groups
260 Participants
are divided into 2 treatment groupsGroup A: Open label placeboExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Repeat jump
Whether participants choose to complete a repeat jump after their initial jump.
Time frame
During the same study session, immediately following completion of the participant's initial jump.Secondary outcomes
1
Self reported stress
Participants self-reported stress related to the jump measured at baseline (prior to the jump) and post-jump. Measured at baseline with the question: How anxious do you feel about the jump today? 0 (Not at all) - 10 (Extremely) Measured post-jump with the question: How anxious were you right before you jumped? 0 (Not at all) - 10 (Extremely)
Time frame
Answered at baseline on the pre-jump questionnaire and immediately after completion of the jump on the post-jump questionnaire, during the same study session.2
Time to jump
The amount of time taken for participants to jump after being clipped on to the main attachment point (rigging plate).
Time frame
During the study session. Time is recorded in seconds. The recording starts when the participant is clipped onto the main attachment point rigging plate and stops recording when they leave the jump platform and drop into the canyon.3
Enjoyment of the jump
Participants self-reported enjoyment of the jump. Measured with the question: Firstly, how much did you enjoy your jump? 0 (Not at all) - 10 (Extremely)
Time frame
Answered immediately after completion of the jump on the post jump questionnaire, during the same study session.4
Willingness to jump again
Participants self-reported willingness to jump again. Measured with the question: If given the opportunity, would you do another jump today? Answer: YES or NO
Time frame
Answered immediately after completion of the jump on the post jump questionnaire, during the same study session.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: