Impact of a Hypnotic Recording on Artifacts in 4D CT in the Context of Stereotactic Body Radiation Therapy for Lung Cancer

NCT07334990 | Not Yet Recruiting

• 1 other identifier: ET25-084
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-center prospective cohort study evaluating the impact of a simple audio recording hypnosis system on the occurrence of artifacts on 4D CT scans in patients requiring SBRT radiotherapy for lung lesions (peripheral or central). The primary objective of the study is to evaluate the use of a hypnotic recording on the reduction of artifacts in 4D CT scans for patients undergoing stereotactic body radiation therapy for lung cancer. The secondary objectives are to evaluate:

• the impact of hypnotic recording on the reduction of artifacts on intrathoracic structures (trachea, main bronchi, diaphragm, lesions, heart, and lungs),
• the regularity of respiratory amplitude,
• the regularity of respiratory rate,
• the volume of Internal Target Volume (ITV),
• the reproducibility of ITV volume,
• patient satisfaction.
• Before this dosimetric scan, the patient will complete a self-administered questionnaire on anxiety: the HADS-A questionnaire (Hospital Anxiety and Depression Scale-only questions relating to anxiety).
• The hypnotic audio recording will be played through the room's speakers. The hypnotic recording is structured in three stages, with a 5-minute induction phase, a 5-minute working phase, and finally a 5-minute return phase.
• Following the first radiotherapy session and for all patients included in the study, a 4D dosimetric scan will be performed using the hypnotic recording again, as described above, in order to assess the inter-fraction reproducibility of the ITV volume.

Conditions

Stereotactic Body Radiation Therapy; Lung Lesions

Keywords

Hypnosis

Outcome Measures

Primary Outcomes (1)

• Difference between the proportion of 4D CT scans acquired under normal conditions and showing at least 1 artifact at the level of the lesion and the proportion of 4D CT scans acquired under hypnosis and showing >= 1artifact at the level of the lesion

  Throught study completion, an average of 1 month

Secondary Outcomes (6)

• The proportion of 4D CT scans showing at least one artifact in lung volume for both acquisition conditions (with and without hypnotic recording)

  Throught study completion, an average of 1 month

• The difference between the minimum and maximum respiratory amplitude for the two acquisition conditions (with and without hypnotic recording);

  Throught study completion, an average of 1 month

• The difference between the minimum and maximum respiratory rate for the two acquisition conditions (with and without hypnotic recording);

  Until the end of the study

• The difference in ITV volume between the two acquisition conditions (with and without hypnotic recording)

  Throught study completion, an average of 1 month

• The difference in ITV size, in the craniocaudal axis, on 4D CT scans acquired under hypnotic recording

  Throught study completion, an average of 1 month

Study Arms (1)

Hypnotic record

EXPERIMENTAL

Other: Hypnotic record

Interventions

Hypnotic record OTHER

The hypnotic audio recording will be played through the room's speakers. The hypnotic recording is structured in three stages, with a 5-minute induction phase, a 5-minute working phase, and finally a 5-minute return phase.

Hypnotic record

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years,
• Indication for lung SBRT, peripheral or central lesion,
• Patient new to hypnosis (medical or stage hypnosis),
• Patient covered by social security or equivalent,
• Dated and signed consent form.

You may not qualify if:

• Indication for treatment with abdominal compression,
• Patient undergoing treatment for multiple lesions in the same treatment sequence,
• Patient with an ultra-central lesion (distance to the mediastinum \< 2 cm),
• Patient already included in this protocol,
• Cognitive or physical disorders preventing the trial from proceeding smoothly,
• Patient with one or more active psychotic disorders (such as schizophrenia),
• Patients suffering from severe dissociative disorders,
• Patient who does not understand French or is deaf,
• Pregnant or breastfeeding women,
• Patient under guardianship or curatorship or deprived of liberty.

Sponsors & Collaborators

• Centre Leon Berard: lead

Central Study Contacts

Céline KERMORGANT

CONTACT

+33 4 78 78 28 28; celine.kermorgant@lyon.unicancer.fr

Séverine METZGER

CONTACT

+33478782786

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 12, 2026
• Study Start: December 30, 2025
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: January 12, 2026

Record last verified: 2025-12