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OpenTrials
Completed

NCT Number: NCT05815056

Comparaison Between Digital and Drug Induced Sedation in Veinous Access Device Implantation

The goal of this clinical trial is to compare in patients who need an implantation of a veinous access device the sedation with anesthesiologic drugs and with hypnosis using virtual reality material. The main question it aims to answer is:

• is hypnosis using virtual reality as safe and powerfull than usual anesthesiologic drugs.

Participants will complete a preoperative and postoperative questionnaire. They will be contacted by phone pre and postoperatively.

If there is a comparison group: Researchers will compare drug induced sedation and hypnosis induced by virtual reality to see if they are similar in efficacy and sides effects.

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Key information

Conditions

Oncology Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR de Huy

Huy, 4500, Belgium

About this study

This study has two arms. All patients has the same preparation to surgery. They had lorazepam 2.5 mg 30 minutes before the surgery. In operative theater, they are randomly chosen between anesthetic protocol (sufentanyl 5mg intravenous) or digital sedation (Sedakit(R) ) with hypnosis induced by virtual reality.

Patients complete an anxiety test (hamilton scale) 2 days before the surgery and 2 days after the surgery. They are called by an external psychiatrist 1 day before the surgery and 3 days after to evaluate the anxiety link to the procedure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • need for a venous device implantation

Exclusion criteria

  • need for a general anaesthesia
  • unability to give oral consent
  • under 18 years

Treatment and study plan

Sedakit (R) using hypnosis induced by the virtual reality device

Device

we use the virtual reality device and no medication during the surgery

Other names: Oncomfort

drug intervention

Drug

using sufentanyl 5mg intravenously during the surgery

Other names: medical sedation

Primary outcomes

  1. successful implantation of a veinous access device

    Time frame: immediately after surgery

    we evaluate if the veinous access was implanted successfully with digital or drug sedation

Secondary outcomes

  1. patient comfort

    Time frame: during the surgery

    we evaluate if the patient needed additional pain killers during the procedure

  2. implantation lenght

    Time frame: during the surgery

    we evaluate the length of the implantation in minutes with the drug or digital sedation

  3. feeling lenght

    Time frame: immediately after the surgery

    we evaluate the length of the implantation felt by the patient using drug or digital sedation

  4. post operative anxiety using the hamilton anxiety scale

    Time frame: 2 days after the surgery

    we do a post operative test to evaluate the level of anxiety after the procedure

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Regional de Huy

Other

Registry information

Official study title

Comparaison Between Virtual Reality Hypnosis and Drug Induced Sedation in Veinous Access Device Implantation

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 18, 2023
Registry last updated
Apr 18, 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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