Hypnotic Communication in Cardiology: A Randomized Controlled Trial

NCT07424209 | Recruiting

• 1 other identifier: CE 023/2025
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

Brief Summary

Undergoing medical procedures, especially surgical ones, is a significant source of emotional stress for patients. Emotions like anxiety, fear, anger, and depression often accompany such experiences and can negatively impact clinical outcomes. Preoperative anxiety, in particular, affects nearly half of all surgical patients and can lead to complications such as hemodynamic instability, increased medication needs, and prolonged recovery times. Managing this emotional distress is therefore a priority. While pharmacological strategies are commonly used, growing attention is being given to non-drug interventions such as music, art, and play therapies. One such technique is hypnotic communication-a method that uses empathetic, suggestion-based language to influence emotional and physical states without formal hypnotic induction. This technique has roots in anesthesiology and has shown promise in reducing pain and anxiety during medical procedures. The proposed study aims to evaluate the effectiveness of hypnotic communication in reducing emotional distress in patients undergoing elective coronary angiography. This will be done through a randomized controlled trial involving 306 adult patients at the Cardiology Unit of the Ospedale degli Infermi in Biella, Italy. Participants will be randomly assigned to either an experimental group receiving hypnotic communication alongside standard care, or a control group receiving standard care only. The hypnotic session, delivered by trained nurses, will begin before the procedure and continue until it ends, following a five-phase structure (pre-induction, induction, core, de-induction, and closure). The primary outcome is the patient's emotional state-specifically stress, anxiety, depression, anger, and need for help-measured before and after the procedure using the Emotion Thermometer Tool. Secondary outcomes include post-procedural pain (measured 15 and 60 minutes after) and patient satisfaction with the communication technique. The study is designed with a type I error rate of 0.05 and 80% statistical power, and recruitment is expected to last 24 months. Data will be anonymized, securely stored, and analyzed using appropriate statistical methods. Ethical approval and informed consent are integral parts of the protocol. By investigating the emotional and clinical impact of hypnotic communication, the study hopes to support its integration into routine care practices, offering a simple, safe, and cost-effective method to enhance patient well-being during invasive procedures.

Conditions

Psychological Distress; Pain; Anxiety

Keywords

Hypnosis; Psychological distress; Coronary Angiography; Pain; Anxiety

Outcome Measures

Primary Outcomes (1)

• Emotional state (stress, anxiety, depression, anger, and need for help), assessed with the Italian version of the Emotion Thermometer Tool

  Emotional state (stress, anxiety, depression, anger, and need for help), assessed using the Italian version of the Emotion Thermometer Tool. This is a visual-analogue scale that evaluates the combination of five emotional dimensions: * Stress * Anxiety * Depression * Anger * Need help Each dimension is scored on a scale from 0 to 10, where 0 indicates "not at all" and 10 indicates "extremely." For individual items, scores from 0 to 3 are considered low, while scores from 4 to 10 are considered high. As for the total score of the scale, a score between 9 and 14 is considered mild, 15 to 20 is moderate, and scores above 20 are considered severe.

  Immediately before preparation for transfer to the hemodynamics laboratory and 60 minutes after completion of the coronary angiography procedure.

Secondary Outcomes (2)

• Pain, assessed with NRS

  At 15 and 60 minutes post-procedure

• Level of patient's satisfaction

  Within 60 minutes after completion of the coronary angiography procedure.

Study Arms (2)

Hypnotic Communication

EXPERIMENTAL

In the intervention group, adult patients (≥18 years), of both sexes, referred to the Cardiology Unit and scheduled for elective coronary angiography, who are able to read and understand Italian, will receive a session of hypnotic communication in addition to standard care. This session will be conducted by nursing staff trained in hypnotic communication. It will begin at the patient's bedside before the procedure and continue throughout the coronary angiography, ending when the procedure is complete. The communication technique follows a structured five-phase model: pre-induction, induction, core (body), de-induction, and closure (tail). It uses empathetic, suggestive language without formal hypnosis, aiming to reduce emotional distress (such as anxiety, stress, and fear) and improve the overall patient experience. Patients may withdraw from the session at any time if they feel discomfort or no longer wish to participate.

Other: Hypnotic Communication

Control group

NO INTERVENTION

Patients in the control group will receive standard of care only.

Interventions

Hypnotic Communication OTHER

Hypnotic communication follows a process consisting of five distinct phases (Granone, 1989): 1. Pre-induction 2. Induction 3. Core (Body) 4. De-induction 5. Closure (Tail) The intervention will be delivered by nursing staff trained and experienced in hypnotic communication. The session will begin at the patient's bedside and continue throughout the entire procedure, concluding upon its completion.

Hypnotic Communication

Eligibility Criteria

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

You may qualify if:

• Adult patients (≥18 years), of both sexes, referred to the Cardiology Unit and scheduled for elective coronary angiography;
• Ability to read and understand the Italian language.

You may not qualify if:

• Cognitive impairment or neurodegenerative disorders that may compromise the ability to provide informed consent;
• Psychiatric disorders, neurodegenerative diseases, or major depressive states.

Sponsors & Collaborators

• Università degli Studi del Piemonte Orientale Amedeo Avogadro: lead
• Azienda Sanitaria Locale Biella: collaborator

Study Sites (1)

Azienda Sanitaria Locale di Biella

Ponderano, Italy, 13875, Italy

RECRUITING

Related Publications (13)

• Scaglione M, Battaglia A, Lamanna A, Cerrato N, Di Donna P, Bertagnin E, Muro M, Alberto Caruzzo C, Gagliardi M, Caponi D. Adjunctive hypnotic communication for analgosedation in subcutaneous implantable cardioverter defibrillator implantation. A prospective single center pilot study. Int J Cardiol Heart Vasc. 2021 Jul 13;35:100839. doi: 10.1016/j.ijcha.2021.100839. eCollection 2021 Aug.

  PMID: 34307829 BACKGROUND

• Wang R, Huang X, Wang Y, Akbari M. Non-pharmacologic Approaches in Preoperative Anxiety, a Comprehensive Review. Front Public Health. 2022 Apr 11;10:854673. doi: 10.3389/fpubh.2022.854673. eCollection 2022.

  PMID: 35480569 BACKGROUND

• Scaglione M, Battaglia A, Di Donna P, Peyracchia M, Bolzan B, Mazzucchi P, Muro M, Caponi D. Hypnotic communication for periprocedural analgesia during transcatheter ablation of atrial fibrillation. Int J Cardiol Heart Vasc. 2019 Jul 27;24:100405. doi: 10.1016/j.ijcha.2019.100405. eCollection 2019 Sep.

  PMID: 31388561 BACKGROUND

• Ruiz Hernandez C, Gomez-Urquiza JL, Pradas-Hernandez L, Vargas Roman K, Suleiman-Martos N, Albendin-Garcia L, Canadas-De la Fuente GA. Effectiveness of nursing interventions for preoperative anxiety in adults: A systematic review with meta-analysis. J Adv Nurs. 2021 Aug;77(8):3274-3285. doi: 10.1111/jan.14827. Epub 2021 Mar 23.

  PMID: 33755246 BACKGROUND

• Noergaard MW, Hakonsen SJ, Bjerrum M, Pedersen PU. The effectiveness of hypnotic analgesia in the management of procedural pain in minimally invasive procedures: A systematic review and meta-analysis. J Clin Nurs. 2019 Dec;28(23-24):4207-4224. doi: 10.1111/jocn.15025. Epub 2019 Sep 3.

  PMID: 31410922 BACKGROUND

• Mitchell AJ, Baker-Glenn EA, Granger L, Symonds P. Can the Distress Thermometer be improved by additional mood domains? Part I. Initial validation of the Emotion Thermometers tool. Psychooncology. 2010 Feb;19(2):125-33. doi: 10.1002/pon.1523.

  PMID: 19296462 BACKGROUND

• Monolo D, Barisone M, Cordio G, Della Sanita M, Airoldi C, Radrizzani D, Bassi E, Dal Molin A, Gallione C. The use of hypnotic communication in PICC placement: randomized controlled trial study. Am J Clin Hypn. 2024 Sep;66(3):249-261. doi: 10.1080/00029157.2023.2258946. Epub 2023 Oct 3.

  PMID: 37788329 BACKGROUND

• Jones HG, Rizzo RRN, Pulling BW, Braithwaite FA, Grant AR, McAuley JH, Jensen MP, Moseley GL, Rees A, Stanton TR. Adjunctive use of hypnosis for clinical pain: a systematic review and meta-analysis. Pain Rep. 2024 Sep 10;9(5):e1185. doi: 10.1097/PR9.0000000000001185. eCollection 2024 Oct.

  PMID: 39263007 BACKGROUND

• Hauser W, Hagl M, Schmierer A, Hansen E. The Efficacy, Safety and Applications of Medical Hypnosis. Dtsch Arztebl Int. 2016 Apr 29;113(17):289-96. doi: 10.3238/arztebl.2016.0289.

  PMID: 27173407 BACKGROUND

• Fusco N, Bernard F, Roelants F, Watremez C, Musellec H, Laviolle B, Beloeil H; Effect of Language and Confusion on Pain During Peripheral Intravenous Catheterization (KTHYPE) group. Hypnosis and communication reduce pain and anxiety in peripheral intravenous cannulation: Effect of Language and Confusion on Pain During Peripheral Intravenous Catheterization (KTHYPE), a multicentre randomised trial. Br J Anaesth. 2020 Mar;124(3):292-298. doi: 10.1016/j.bja.2019.11.020. Epub 2019 Dec 18.

  PMID: 31862159 BACKGROUND

• Friedrich S, Reis S, Meybohm P, Kranke P. Preoperative anxiety. Curr Opin Anaesthesiol. 2022 Dec 1;35(6):674-678. doi: 10.1097/ACO.0000000000001186. Epub 2022 Sep 21.

  PMID: 36131642 BACKGROUND

• Granone, F. (1989) Trattato di ipnosi. Torino: UTET.

  BACKGROUND

• Abate SM, Chekol YA, Basu B. Global prevalence and determinants of preoperative anxiety among surgical patients: A systematic review and meta-analysis. Vol. 25, International Journal of Surgery Open. Elsevier Ltd; 2020. p. 6-16.

  BACKGROUND

Related Links

• Revised Emotion Thermometer, Italian.

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Simona Milani, MSN

  Azienda Sanitaria Locale di Biella

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Dal Molin, Associate Professor, PhD

CONTACT

+39 0321660607; alberto.dalmolin@med.uniupo.it

Dino Stefano Di Massimo, MSN

CONTACT

01515153432; dinostefano.dimassimo@aslbi.piemonte.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 20, 2026
• Study Start: June 9, 2025
• Primary Completion (Estimated): June 9, 2027
• Study Completion (Estimated): October 9, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)