Evaluation and Management of Parturients' Pain Intensity

Labor Pain Clinical Trial

Official title:

Evaluation and Management of Parturients' Pain Intensity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04662450
• Other study ID #: 2017P001416
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: December 2026

Study information

• Verified date: February 2023
• Source: Harvard Medical School (HMS and HSDM)
• Contact: Jie Zhou, MD, MS, MBA
• Phone: 617-732-8220
• Email: jzhou[@]mgh.harvard.edu
• Is FDA regulated: No
• 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: Not yet recruiting
• Enrollment: 90
• 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

Related Conditions & MeSH terms

• Labor Pain
• Pain

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)