Evaluation and Management of Parturients' Pain Intensity

Not Applicable

Withdrawn

• Conditions: Labor Pain
• Interventions: Behavioral: ABM affective pain stimuli; Behavioral: ABM sensory pain stimuli; Behavioral: Placebo

• Registration Number: NCT04662450
• Lead Sponsor: Harvard Medical School (HMS and HSDM)

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-07-31
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-13
• Study Start: 2024-09
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Affective pain stimuli group	ABM affective pain stimuli	affective/neutral word pairs
Sensory pain stimuli group	ABM sensory pain stimuli	sensory/neutral word pairs
Control group	Placebo	affective/neutral and sensory/neutral word pairs

Primary Outcome Measures

Name	Time	Method
Effects of Attentional Bias Modification (ABM) on labor pain	4 weeks (starting from 36-week gestation)	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.