The Economic and Cognitive Effects of Pain Reduction

NCT03437460 | Terminated

• 1 other identifier: 825454
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

Physical pain is a common but largely overlooked aspect of the lives of the poor. Not only does pain directly reduce life quality and happiness, it may also hamper cognitive function and, consequently, decision-making, productivity, and earnings. Workers with chronic pain may work fewer days, take longer breaks, and make less-considered choices regarding inputs; all outcomes that would reduce output and lead to greater impoverishment or impede the productivity and profitability of microenterprises and firms. The investigators will take the first steps in understanding the broader causal impact of physical pain on the cognitive and economic lives of the poor via a randomized controlled trial (RCT). 450 low-income women in Chennai, India, will be assigned to one of three treatment arms: 600 mg of over-the-counter pain medication, a placebo pill, or no medication. The research will quantify the causal impact of reduced pain on previously unstudied outcomes essential to escaping poverty including cognitive function, productivity, and earnings.

Conditions

Pain, Chronic

Keywords

Productivity; Cognitive Function; Decision Making; Well-Being; Health; Labor

Outcome Measures

Primary Outcomes (9)

• Change in pain levels - visual analog scale

  Visual analog scale pain levels will measure the participant's self-assessed pain levels throughout the day. On the morning of Day 2 of the study, visual analog scale pain levels are recorded after each of the 4 cognitive tasks and after 30 minutes of flower stringing. Visual analog scale pain levels are reported throughout the afternoon of study Day 2 after each cognitive task and after every 30 minutes of flower stringing, and then compared to the baseline measures.

  Change from baseline to end of Day 2

• Change in pain levels - cold pressor task

  Cold pressor task will measure the participant's pain tolerance. To assess a baseline tolerance, participants are asked to place their hand in cold water for 5 seconds to become accustomed to the task, and then for 20 seconds, after which they report their pain level. After lunch, participants complete the cold pressor duration, during which they hold their hand in cold water for as long as they want, up to 2 minutes. This measure is compared to the baseline measure from the morning.

  Change from baseline to end of Day 2

• Change in cognitive function: impulse control

  The Hearts and Flowers task is completed once in the morning as a baseline measure and twice in the afternoon, to compare to the baseline. The task is compensated according to performance.

  Change from baseline to end of Day 2

• Change in cognitive function: simple memory

  The Corsi block-span task is completed once in the morning as a baseline measure and twice in the afternoon, to compare to the baseline. The task is compensated according to performance.

  Change from baseline to end of Day 2

• Change in cognitive function: working memory

  The N-back task is completed once in the morning as a baseline measure and twice in the afternoon, to compare to the baseline. The task is compensated according to performance.

  Change from baseline to end of Day 2

• Change in cognitive function: simple attention

  The Psychomotor Vigilance is completed once in the morning as a baseline measure and twice in the afternoon, to compare to the baseline. The task is compensated according to performance.

  Change from baseline to end of Day 2

• Change in flower-stringing productivity: weight of flower buds used

  Flower stringing productivity (weight of buds used) baseline is measured in the morning after a 30 minute flower stringing session. This outcome is compared to the weight of flower buds used in the afternoon flower stringing sessions, which span 150 minutes and 30 minutes.

  Change from baseline to end of Day 2

• Change in flower-stringing productivity: length of garland

  Flower stringing productivity (length of garland) baseline is measured in the morning after a 30 minute flower stringing session. This outcome is compared to the length of garland in the afternoon flower stringing sessions, which span 150 minutes and 30 minutes.

  Change from baseline to end of Day 2

• Change in flower-stringing productivity: density of garland

  Flower stringing productivity (density of garland) baseline is measured in the morning after a 30 minute flower stringing session. This outcome is compared to the density of garland in the afternoon flower stringing sessions, which span for 150 minutes and then for 30 minutes.

  Change from baseline to end of Day 2

Study Arms (3)

Ibuprofen 600mg

ACTIVE COMPARATOR

Treatment group participants receive a single 600 mg of over-the-counter ibuprofen.

Drug: Ibuprofen 600 mg

Prenatal vitamins

PLACEBO COMPARATOR

The placebo group participants receive a single dose of a pre-natal multivitamin.

Dietary Supplement: Prenatal vitamins

Control group

NO INTERVENTION

Control-group participants are not provided with any treatment and they are fully informed regarding their treatment status.

Interventions

Ibuprofen 600 mg DRUG

The investigators administer one single 600 mg dose of ibuprofen immediately before lunch. Participants are then asked to complete the cold pressor task, flower stringing sessions, and cognitive tasks.

Also known as: Brufen

Ibuprofen 600mg

Prenatal vitamins DIETARY_SUPPLEMENT

The investigators administer one single prenatal multivitamin immediately before lunch. Participants are then asked to complete the cold pressor task, flower stringing sessions, and cognitive tasks.

Prenatal vitamins

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be between the ages of 25 and 65
• Must speak Tamil as their primary language
• Must report that they have suffered from chronic physical pain in the last week.

You may not qualify if:

• An adverse relation related to pain medication in the past
• Kidney disease (ongoing or kidney stone within the past 3 years)
• Gastrointestinal (GI) discomfort
• History of complicated peptic ulcer disease
• Currently using NSAIDs, aspirin, corticosteroids or anticoagulants
• Allergies to any of the medicines use in the study
• History of gastric bleeding
• History or existing liver disease
• Surgery within 1 to 2 weeks after the study
• Hypertension
• Heart disease or failure
• Diabetes
• Lupus
• Blood clotting
• Actual or potential pregnancy

Sponsors & Collaborators

• University of Pennsylvania: lead
• Institute for Financial Management and Research: collaborator

Study Sites (1)

Institute for Financial Management and Research

Chennai, Tamil Nadu, 600034, India

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Ibuprofen; Prenatal Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Patient Care; Therapeutics; Maternal Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Frank Schilbach, Ph.D.

  MIT Department of Economics

  PRINCIPAL INVESTIGATOR

• Heather Schofield, Ph.D.

  University of Pennsylvania, Perelman School of Medicine and Wharton Business School

  PRINCIPAL INVESTIGATOR

• Anuj Shah, Ph.D.

  University of Chicago, Booth School of Business

  PRINCIPAL INVESTIGATOR

• Sendhil Mullainathan, Ph.D.

  Harvard University

  PRINCIPAL INVESTIGATOR

• Emma Dean, M.S.

  University of Pennsylvania, Wharton School of Business

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: February 19, 2018
• Study Start: May 10, 2017
• Primary Completion: August 12, 2017
• Study Completion: August 12, 2017
• Last Updated: August 3, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will be available upon completion of the study with additional time to allow for merging, cleaning, and publication.
• Access Criteria: Data are available upon request following publication.

Locations

IN (1)