Labor PainNCT04662450
Evaluation and Management of Parturients' Pain Intensity
A study testing ABM affective pain stimuli and ABM sensory pain stimuli in people with Labor Pain, run by Harvard Medical School (HMS and HSDM).
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- ABM affective pain stimuli and ABM sensory pain stimuli
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Parturients who are at 36 weeks gestation (at time of starting the study)
Who cannot join
- Any patient who refuses
- Patients with impaired decision-making capacity
- Patients who are blind or extremely visually impaired
- Patients who cannot understand or read English
About this study
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.
Read the 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.
- Conditions
- Labor Pain
- Being tested
- ABM affective pain stimuli, ABM sensory pain stimuli, Placebo
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABM affective pain stimuliBehavioural
Patients undergo ABM training to shift attention away from affective pain stimuli
ABM sensory pain stimuliBehavioural
Patients undergo ABM training to shift attention away from sensory pain stimuli
PlaceboBehavioural
Patients undergo ABM training to receive affective/neutral and sensory/neutral word pairs
| Study group | Role | What they receive |
|---|---|---|
| Affective pain stimuli group | Experimental | affective/neutral word pairs Receives: Behavioral: ABM affective pain stimuli |
| Sensory pain stimuli group | Experimental | sensory/neutral word pairs Receives: Behavioral: ABM sensory pain stimuli |
| Control group | Placebo comparator | affective/neutral and sensory/neutral word pairs Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks (starting from 36-week gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study startSep 2024 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: Difficulty in recruiting patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Zhou, Harvard Medical School (HMS and HSDM)
- Investigators
- Jie Zhou, MD, MS, MBA, Principal investigator, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662450
- Sponsor's protocol ID
- 2017P001416
- Status last verified
- May 2024
- First submitted
- 31 Jul 2018
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27327608Schoth 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.
PubMed 23731349Duschek 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.
PubMed 24447855
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Management of Parturients' Pain Intensity
- ClinicalTrials.gov ID
- NCT04662450
- Acronym / sponsor ID
- 2017P001416
- Conditions
- Labor Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty in recruiting patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Affective pain stimuli group | Experimental | Behavioral: ABM affective pain stimuliaffective/neutral word pairs |
| Sensory pain stimuli group | Experimental | Behavioral: ABM sensory pain stimulisensory/neutral word pairs |
| Control group | Placebo comparator | Behavioral: Placeboaffective/neutral and sensory/neutral word pairs |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Parturients who are at 36 weeks gestation (at time of starting the study)
Key exclusion criteria (4 listed)
- Any patient who refuses
- Patients with impaired decision-making capacity
- Patients who are blind or extremely visually impaired
- Patients who cannot understand or read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABM affective pain stimuliPatients undergo ABM training to shift attention away from affective pain stimuli | Behavioural | Affective pain stimuli group |
| ABM sensory pain stimuliPatients undergo ABM training to shift attention away from sensory pain stimuli | Behavioural | Sensory pain stimuli group |
| PlaceboPatients undergo ABM training to receive affective/neutral and sensory/neutral word pairs | Behavioural | Control group |
Primary outcome
Effects of Attentional Bias Modification (ABM) on labor pain
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Background: PubMed 27327608Todd 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.
- Results publication: PubMed 23731349Schoth 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.
- Results publication: PubMed 24447855Duschek 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Zhou, MD, MS, MBA principal investigator
Harvard Medical School (HMS and HSDM)
Questions about this trial
What is this clinical trial studying?
A study testing ABM affective pain stimuli and ABM sensory pain stimuli in people with Labor Pain, run by Harvard Medical School (HMS and HSDM).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of Attentional Bias Modification (ABM) on labor pain (time frame: 4 weeks (starting from 36-week gestation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04662450, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.