Placebo Versus Nocebo: Effects on Pain and Anxiety During Local Anaesthetic Infiltration in Parturient Undergoing Elective Caesarean Delivery

NCT04975659 | Completed

• 1 other identifier: UKM PPl/111/8/JEP-2020-011
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized trial compared placebo and nocebo effect over anaesthetist-patient communication on pain and anxiety score during local anaesthetic (LA) skin infiltration in parturient undergoing caesarean delivery under regional anaesthesia (RA). A secondary objective was to determine if education level and previous RA experience affect pain and anxiety scores. Parturients scheduled for elective caesarean delivery were randomised into Placebo (P) or Nocebo (N) group. Baseline Amsterdam Preoperative Anxiety \& Information Scale (APAIS0) were obtained. Standardised scripts describing the LA skin infiltration for RA were used during the pre-anaesthetic review. (N) group were explained with words like "pain, prick, sharp" while words like "numb, comfort, tolerable" were used in the (P) group, avoiding "painful" expressions. The same scripts will be repeated before skin infiltration during the RA procedure. On the day of surgery, a second (APAIS1) was obtained upon arrival to the theatre. Pain score using the numerical rating scale (NRS) was assessed after LA infiltration.

Conditions

Communication

Keywords

Placebo; Nocebo; Pain; Anxiety; Local Skin Infiltration

Outcome Measures

Primary Outcomes (3)

• Pain score

  Pain score during local anaesthetic infiltration using Numerical Rating Scale (NRS) (range 0-10) where 0 is "no pain at all" and 10 is " worst pain ever felt"

  Throughout study completion, average of 10 months

• Baseline anxiety score

  Validated questionnare using the Amsterdam Preoperative Anxiety \& Information Scale. (APAIS) (Range 6-30). Higher scores mean higher anxiety level

  Through study completion, average of 10 months

• Preoperative anxiety score

  Validated questionnare using the Amsterdam Preoperative Anxiety \& Information Scale. (Range 6-30). Higher scores mean higher anxiety level

  Through study completion, average of 10 months

Secondary Outcomes (2)

• Association of Education level on Pain and anxiety score

  Through study completion, average of 10 months

• Association of past history of regional anesthesia on Pain and anxiety score

  Through study completion, average of 10 months

Study Arms (2)

Nocebo

ACTIVE COMPARATOR

We informed subjects in the N group a negative suggestion, using the following script: "During the local anaesthetic injection, you are going to feel a sharp prick at your back; this is usually the painful part of the procedure"

Behavioral: Placebo and Nocebo effect

Placebo

PLACEBO COMPARATOR

We informed subjects in the P group a positive suggestion, using the following script: "We will administer some local anaesthetic to numb your back; this will allow the procedure to be more comfortable and tolerable for you."

Behavioral: Placebo and Nocebo effect

Interventions

Placebo and Nocebo effect BEHAVIORAL

Positive suggestion and words is used on Placebo group Negative suggestion and words is used on Nocebo group

Nocebo; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anaesthesiology (ASA) II category parturient listed for elective caesarean delivery.
• Can understand intended verbal communication

You may not qualify if:

• receiving any form of analgesia within 6 hours before the study
• chronic pain,
• anxiety disorders
• allergy to Local Anaesthetic drugs

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

Hospital Canselor Tuanku Muhriz,

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (4)

• Mohd Fahmi Z, Lai LL, Loh PS. Validation of the Malay version of the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Med J Malaysia. 2015 Aug;70(4):243-8.

  PMID: 26358022 BACKGROUND

• Dutt-Gupta J, Bown T, Cyna AM. Effect of communication on pain during intravenous cannulation: a randomized controlled trial. Br J Anaesth. 2007 Dec;99(6):871-5. doi: 10.1093/bja/aem308. Epub 2007 Oct 30.

  PMID: 17977860 BACKGROUND

• Varelmann D, Pancaro C, Cappiello EC, Camann WR. Nocebo-induced hyperalgesia during local anesthetic injection. Anesth Analg. 2010 Mar 1;110(3):868-70. doi: 10.1213/ANE.0b013e3181cc5727. Epub 2009 Dec 30.

  PMID: 20042440 RESULT

• Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.

  PMID: 8623940 RESULT

MeSH Terms

Conditions

Communication; Pain; Anxiety Disorders

Interventions

Nocebo Effect

Condition Hierarchy (Ancestors)

Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Placebo Effect; Effect Modifier, Epidemiologic; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded from their randomization. Personnel assessing the pain score is blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer and Consultant Anesthesiologist , Department of Anesthesia and Intensive Care

Model Details: We randomised participants into either the nocebo (N) or placebo (P) group using computer generated numbers

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 23, 2021
• Study Start: July 13, 2020
• Primary Completion: May 21, 2021
• Study Completion: May 28, 2021
• Last Updated: May 19, 2023

Record last verified: 2023-05

Locations

MY (1)