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Can a short talk with biofeedback ease trauma after cancer surgery?

NCT ID NCT07712120

Symptom relief Sponsor: University of Turin, Italy Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study tests whether two 60-minute psychological sessions that include biofeedback can help reduce post-traumatic stress symptoms in people undergoing surgery for head and neck cancer. Participants are randomly assigned to receive the intervention or standard care. The goal is to see if this brief support improves emotional well-being, body image, and quality of life after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
brief clinical psychological intervention using biofeedback techniques
What this could lead to
If effective, this approach could offer a simple, non-drug way to help head and neck cancer patients cope with trauma and improve their recovery.
What could go wrong
This is a small pilot study, so results may not apply broadly. The intervention is brief and may not be enough for severe distress.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 58 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria Participants must meet all of the following criteria: * Patients with a diagnosis of head and neck cancer scheduled to undergo demolitive surgery of the oral cavity or oropharynx, with or without simultaneous flap reconstruction. * Age ≥18 years at the time of signing the informed consent form. * Ability to understand and communicate in Italian. Exclusion Criteria Participants will be excluded if they: * Are unable to provide written informed consent. * Have a diagnosed psychiatric disorder. * Have a diagnosed neurocognitive impairment. * Are currently undergoing psychological or psychotherapeutic treatment.

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Demolitive surgical procedures on the oral cavity or oropharynx, with or without simultaneous reconstruction using flaps Head and neck cancer Surgery for head and neck cancer patients

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Head and Neck Cancer Unit, Asl Città di Torino

    RECRUITING

    Turin, Italy

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