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Completed

NCT Number: NCT04975659

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

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.

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Key information

Conditions

Communication Anxiety Disorders Behavior Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Canselor Tuanku Muhriz,

Cheras, Kuala Lumpur, 56000, Malaysia

About this study

We randomised participants into either the nocebo (N) or placebo (P) group. We obtained a baseline anxiety score (APAIS0) using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) during the pre-anaesthesia visit. Following that, 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 most painful part of the procedure". On the other hand, we used a positive suggestion on the P group: "We will administer some local anaesthetic to numb your back; this will allow the procedure to be more comfortable and tolerable for you." We obtain a second anxiety score (APAIS1) in the operating theatre before the caesarean section. We carried out either spinal anaesthesia or continuous spinal epidural according to standard hospital protocol and indication. Before the LA skin infiltration, the anaesthetist repeats the same script to the subjects according to the prior randomisation. Five millilitres of lignocaine 2% is injected intradermally and subcutaneously by the anaesthetist into interspinous space in a single pass through a 22-gauge needle to create a skin wheal.

During the LA infiltration, only the attending anaesthetist performing the procedure gave participants verbal instructions; other personnel remained silent throughout. We recorded the presence of vocalisation of pain, withdrawal movement or facial grimacing. Immediately after the LA infiltration, a blinded and trained general anaesthetic nurse or personnel enters the operating theatre to assess the subjects' pain score using the numerical rating scale (NRS). After collection of the pain score, the anaesthetist performed the remaining anaesthetic procedure as per clinical routine.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Placebo and Nocebo effect

Behavioral

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

Primary outcomes

  1. Pain score

    Time frame: Throughout study completion, average of 10 months

    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"

  2. Baseline anxiety score

    Time frame: Through study completion, average of 10 months

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

  3. Preoperative anxiety score

    Time frame: Through study completion, average of 10 months

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

Secondary outcomes

  1. Association of Education level on Pain and anxiety score

    Time frame: Through study completion, average of 10 months

    Correlation between subjects education level on pain score (NRS) and anxiety score (APAIS)

  2. Association of past history of regional anesthesia on Pain and anxiety score

    Time frame: Through study completion, average of 10 months

    Correlation between subjects previous experience of regional anesthesia on pain score (NRS) and anxiety score (APAIS)

Sponsors and collaborators

Lead sponsor

Universiti Kebangsaan Malaysia Medical Centre

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 23, 2021
Registry last updated
May 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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