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Completed

NCT Number: NCT05276882

Improved Rehabilitation After Surgery and Hypnosis: Benefits Potentiated by a Preoperative Consultation

Today, patient management in the context of scheduled surgery must meet new requirements. The understanding of surgical aggression, the evolution of anesthesia and surgery techniques have allowed the birth of the protocol of Improved Rehabilitation After Surgery. The objective is a pain-free surgery, with a minimum of risks, with a global management of the patient and an active participation.

In 2019, the Nice University Hospital developed this program. Other non-medicinal techniques could promote the evolution of this program such as integrative medicine with, in this study case, hypnosis. Since 2002, thanks to its widely recognized effectiveness in the treatment of pain and in helping with care, its use has developed. A hypnosis session, proposed in the preoperative period, would considerably reduce the patient's anxiety, postoperative pain, a better and faster recovery with an easier healing: objectives of the Improved Rehabilitation After Surgery program. The patient's satisfaction would also be improved thanks to his active participation, in a greater comfort, which the investigators want to demonstrate by our work.

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Key information

Conditions

Gynecological Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nice University Hospital

Nice, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female gender
  • Age ≥ 18 years
  • Indication for laparoscopic gynecological surgery eligible for the Improved Rehabilitation After Surgery protocol
  • Understanding of French essential
  • Signature of informed consent
  • Affiliation to a Social Security system

Exclusion criteria

  • Patient with a history of psychiatric pathologies (Schizophrenia, Psychosis, Bipolarity)
  • Deafness, intellectual deficiency not allowing comprehension
  • Pregnant or breastfeeding women
  • Women of childbearing age who are not using an effective method of contraception (pill, intrauterine device, vaginal ring, contraceptive skin patch, subcutaneous hormonal implant, surgical sterilization)
  • Patient under guardianship or deprived of liberty

Treatment and study plan

Hypnosis

Other

It will be an individualized hypnosis session of Ericksonian type. It consists in going through 3 phases: induction, dissociation, suggestion.

The principle is to focus the patient's attention by talking to her or by surprising her, or by making her do an incongruous gesture which will make her focus on a restricted idea. She will reduce her field of consciousness and concentrate. This is where her work will begin, allowing her unconscious to function in order to find her solutions. At this moment, she is particularly receptive to suggestions and the hypnotherapist accompanies and guides her thoughts and her associations of ideas on therapeutic paths. He provokes a unique personal work which aims to promote healing.

pre-surgery consultation

Other

Dialogue with the patient to clarify her expectations.

  • Answers to the patient's questions
  • Precision on the organization of the hospitalization if necessary
  • Information on the postoperative period with postural advice to facilitate the first getting up with less discomfort, and postures promoting rest in the postoperative period
  • Information on relaxation techniques and their interest (abdominal breathing)

Primary outcomes

  1. Patient anxiety

    Time frame: Up to 2 months

    Evolution of the patient's anxiety between the initial consultation and the day of the surgery.

    Anxiety will be measured using the Spielberger State Trait Anxiety Inventory (S.T.A.I.) To obtain the state-anxiety score, the scores obtained for the 20 items corresponding to the state-anxiety (items 1 to 20) are added together. If two or more items are not answered, the questionnaire cannot be used.

    The mean score for women in non-anxiety situations was 47.13 with a standard deviation of 10. A score higher than this indicates an anxious state.

    Very high score > 65 High score = 56 to 65 Average score= 46 to 55 Low score=36 to 45 Very low score < or = 35

Secondary outcomes

  1. Patient satisfaction

    Time frame: day of discharge from hospital, average of 7 days

    Patient satisfaction will be assessed using the Enhanced Rehabilitation After Surgery protocol satisfaction questionnaire The questionnaire is composed of 9 questions exploring the patient's general feeling about her care, the clarity of the information received, pain, the Enhanced Rehabilitation After Surgery protocol

  2. length of stay in hospital

    Time frame: the day of discharge from hospital, average of 7 days

    length of stay in hospital defined as the number of days between the day of surgery and discharge

  3. use of injectable analgesic

    Time frame: Day 7 of the surgery

    Comparison of the number of patients having had an injectable analgesic prescription between Day 1 and Day 7 of the surgery (binary yes/no criterion).

    This evaluation is only relevant from Day 1 onwards, because at Day 0 it is very common to have to resort to parenteral analgesia.

  4. speed of cicatrization

    Time frame: Day 7 of the discharge from hospital

    The speed of cicatrization will be evaluated in the postoperative period by means of the patient's logbook, which evaluates the evolution of the wound from day 2.

    The wound will be considered healed as soon as the patient answers that the dressing is clean.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: RACHYP

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 11, 2022
Registry last updated
Oct 15, 2024

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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