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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05511857
Other study ID # LinneausU
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 7, 2022
Est. completion date June 9, 2024

Study information

Verified date September 2022
Source Linnaeus University
Contact Helena Gunnarsson, PhD
Phone +46708432509
Email helena.gunnarsson@lnu.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Physical pain leads to a narrow, egocentric focus on the self, in the here and now, particularly when experienced at high intensity levels. When long-term pains are experienced, this narrow focus could be debilitating, since attention to the pain itself may increase its perceived intensity and it could increase negative emotional processes that further contribute to pain-related suffering. One way of overcoming this could be by adopting a more distant view of oneself and the pain, thereby making the pain more abstract. An established way of creating distance is by reflecting on the self, using one's own name and second or third-person singular pronouns, so called third-person self-talk. Earlier research has reported that a psychologically distant perspective could reduce emotional distress when reflecting on negative experiences, reduce feelings of anger after provocation and to lower blood pressure. Self-distancing should thus help people mentally reconstrue their pain experience and possibly make the pain signals less cognitively salient. In this experimental study, healthy participants will be induced with pain while performing different tasks.


Description:

Physical pain leads to a narrow, egocentric focus on the self, in the here and now, particularly when experienced at high intensity levels. When long-term pain is experienced, this narrow focus could be debilitating, since attention to the pain itself may increase its perceived intensity and it could increase negative emotional processes that further contribute to pain-related suffering. One way of overcoming this could be by adopting a more distant view of oneself and the pain, thereby making the pain more abstract. An established way of creating distance is by reflecting on the self, using one's own name and second or third-person singular pronouns, so called third-person self-talk. Earlier research has reported that a psychologically distant perspective could reduce emotional distress when reflecting on negative experiences, reduce feelings of anger after provocation and lead to lower blood pressure. Self-distancing should thus help people mentally reconstrue their pain experience and possibly make the pain signals less cognitively salient. In the first part of this study, which will be the first registered on ClinicalTrials.gov, we will experimentally induce pain in healthy participants (N = 292) with a cold pressor apparatus. The cold pressor apparatus holds a constant water temperature of 1 degree Celsius, which creates pain in the immersed hand. At the experimental test session, the participant will first be comfortably seated and receive information about the task and the experimental pain induction. They will be instructed to withhold their hand in the cold water for as long as possible, but when they feel that the pain becomes too intense they can choose to remove their hand. After that, a blood pressure measurement will be conducted. Directly after that, the participant will be instructed to put their hand in the cold water-bath (the cold pressor apparatus), and when they put their hand in the cold water a new blood pressure measurement will be conducted. A timer will be started to measure the time in seconds that the participant is able to keep their hand in the cold water. While their hand is in the cold water-bath, the participant will conduct one of the four different interventions (self-distanced, third-person self-talk following a cue-card; self-immersed, first-person self-talk following a cue-card; distraction intervention following a cue-card; no intervention (control)). When the participant removes their hand from the cold water-bath, the time in seconds will be noted and they will immediately be asked to estimate their pain on a Numerical Rating Scale. A short debriefing will conclude the session.


Recruitment information / eligibility

Status Recruiting
Enrollment 292
Est. completion date June 9, 2024
Est. primary completion date June 9, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - No known disease affecting the nervous system. - Swedish comprehension. - Age over 18 years old. - - Exclusion Criteria - Experiencing clinical pain at the test session. - Known disease affecting the nervous system. - Inadequate Swedish comprehension. - Age under 18 years old. - -

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Self-distancing, third-person self-talk.
The participants will engage in self-distancing, third-person self-talk.
Self-immersed, first-person self-talk.
The participants will engage in self-immersed, first-person self-talk.
Distraction
The participants will engage in a distraction task.

Locations

Country Name City State
Sweden Helena Gunnarsson Växjö Kronoberg

Sponsors (1)

Lead Sponsor Collaborator
Linnaeus University

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

Ayduk, Ö., Kross, E. (2010). Analyzing Negative Experiences Without Ruminating: The Role of Self-Distancing in Enabling Adaptive Self-Reflection. Soc Personal Psychol Compass, 841-854. 10.1111/j.1751-9004.2010.00301.

Loewenstein G. Out of control: visceral influences on behavior. Organ Behav Hum Decis Process. 1996;65(3):272-292.

Mischkowski, D., Kross, E., Bushman, B.J. (2012). Flies on the wall are less aggressive: Self-distancing "in the heat of the moment" reduces aggressive thoughts, angry feelings, and aggressive behavior. J Exp Soc Psychol 48, 1187-1191.

Orvell A, Vickers BD, Drake B, Verduyn P, Ayduk O, Moser J, Jonides J, Kross E. Does distanced Self-Talk Facilitate Emotion Regulation Across a Range of Emotionally Intense Experiences? Clin Psych Sci 2021; 9: 68-78.

Outcome

Type Measure Description Time frame Safety issue
Primary Pain tolerance The amount of time in seconds the participant can withhold their hand in the cold pressor test. At the test session, the amount of time in seconds the participant withhold their hand in a cold water bath while engaging in self-talk will be measured. Data will be collected until study completion, approximately 1 year.
Primary Pain intensity The estimated experimental pain intensity on the Numerical Rating Scale. Minimum value of the Numerical Rating Scale is 0, which is equivalent with no pain. Maximum value of the Numerical Rating Scale is 10 which is equivalent of worst imaginable pain. The participant will be asked to estimate their pain from the hand (immersed in cold water) on the Numerical Rating Scale at the experimental test session. Data will be collected until study completion, approximately 1 year.
Primary Pain-related fear The estimated pain-related fear on the Numerical Rating Scale. Minimum value 0 and maximum value 10. The participant will be asked to estimate their pain-related fear accompanying the pain they felt when the hand was immersed in cold water on the Numerical Rating Scale. Data will be collected until study completion, approximately 1 year.
Primary Change in blood pressure before and during pain induction. The difference score between the blood pressure before the pain induction and the blood pressure during the pain induction will be compared between the different groups. For example, the difference score between the blood pressure in the self-distanced, third-person self-talk condition will be compared to the difference score in the self-immersed, first-person self-talk condition. The blood-pressure will be measured at the beginning of each test session and during the pain induction during each condition. Data will be collected until study completion, approximately 1 year..
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