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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04662450
Other study ID # 2017P001416
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 2024
Est. completion date December 2026

Study information

Verified date May 2024
Source Harvard Medical School (HMS and HSDM)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to examine the effects of Attentional Bias Modification (ABM) on the labor pain in parturients. One-third of the participants will undergo ABM training away from affective pain stimuli. One-third of the participants will undergo ABM training away from sensory pain stimuli. The rest of participants will be the control group.


Description:

In recent years, significant attention has been paid to the attentional bias in patients with chronic pain. Studies found that Attentional Bias Modification (ABM) could reduce the pain intensity in participants with chronic pain. The investigator's goal is to evaluate the effects of ABM on labor pain and patient satisfaction with the labor and delivery experience.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2026
Est. primary completion date September 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Parturients who are at 36 weeks gestation (at time of starting the study) Exclusion Criteria: 1. Any patient who refuses 2. Patients with impaired decision-making capacity 3. Patients who are blind or extremely visually impaired 4. Patients who cannot understand or read English

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
ABM affective pain stimuli
Patients undergo ABM training to shift attention away from affective pain stimuli
ABM sensory pain stimuli
Patients undergo ABM training to shift attention away from sensory pain stimuli
Placebo
Patients undergo ABM training to receive affective/neutral and sensory/neutral word pairs

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Harvard Medical School (HMS and HSDM)

References & Publications (3)

Duschek S, Werner NS, Limbert N, Winkelmann A, Montoya P. Attentional bias toward negative information in patients with fibromyalgia syndrome. Pain Med. 2014 Apr;15(4):603-12. doi: 10.1111/pme.12360. Epub 2014 Jan 21. — View Citation

Schoth DE, Georgallis T, Liossi C. Attentional bias modification in people with chronic pain: a proof of concept study. Cogn Behav Ther. 2013;42(3):233-43. doi: 10.1080/16506073.2013.777105. Epub 2013 Jun 4. — View Citation

Todd J, Sharpe L, Colagiuri B. Attentional bias modification and pain: The role of sensory and affective stimuli. Behav Res Ther. 2016 Aug;83:53-61. doi: 10.1016/j.brat.2016.06.002. Epub 2016 Jun 15. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Effects of Attentional Bias Modification (ABM) on labor pain Change in pain threshold and labor pain as measured by Fear of Pain Questionnaire (FPQ), Brief Pain Inventory (BPI) and McGill Pain Questionnaire (MPQ) before and after the ABM training. 4 weeks (starting from 36-week gestation)
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