Effect of Reading a Personal Narrative Book on Emotional Regulation in Women of Childbearing Age Undergoing Hysterectomy (RELIEF)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-42
SponsorGroupe SantéCité SantéCité Enseignement-Recherche-Innovation (GCS SCERI)

About this trial

The goal of this interventional clinical trial involving minimal risks and constraints is to evaluate whether an innovative approach to managing catastrophizing in the preoperative context of hysterectomy improves psychological outcomes compared to usual care in women of childbearing age who have been informed of an indication for hysterectomy.

The main questions it aims to answer are:

* Does the use of a personal narrative book improve adaptive emotional regulation and reduce catastrophizing, anxiety, and depressive symptoms in the preoperative period? * Does this intervention improve postoperative patient satisfaction and reduce the need for additional supportive measures?

Researchers will compare standard care (CNGOF information leaflet with psychological consultation if needed) with an intervention including a personal narrative book in addition to standard care, to see if the intervention improves emotional regulation, psychological well-being, and satisfaction.

Participants will:

* provide explicit oral informed consent; * complete questionnaires on their emotional and psychological experience; * read a personal narrative book if they are randomized to the intervention group.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged 18 years or older and under 43 years of age

Patients with an indication for hysterectomy for a non-malignant condition

Patients who have provided explicit oral consent to participate

Patients covered by the French social security system

Disqualifiers

Women with suspected uterine cancer or high-grade dysplasia

Women participating or having participated to an interventional clinical trial within the 30 days prior to inclusion

Pregnant, breastfeeding, or parturient women

Protected patient: adults under guardianship or other legal protection; persons deprived of liberty by judicial or administrative order; persons hospitalized without consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • personal narrative book

    Other intervention

    Reading a personal narrative book written by a patient who underwent a hysterectomy

Treatment groups

156 Participants
are divided into 2 treatment groups
Group A: Standard careNo intervention 0 interventions
Group B: Intervention ("Personal Narrative" arm)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adaptive regulation

The adaptative regulation is measured using the Cognitive Emotion Regulation Questionnaire - Adaptive (CERQ-A) wich include five adaptive subscales . Scores range from 20 to 100, with higher scores indicating better adaptive regulation.

Time frame
between inclusion (D0) and surgery (S0), occurring 1 to 3 months later.

Secondary outcomes

1

Anxiety and depression

The outcome is measured using the Hospital Anxiety and Depression Scale (HADS). The scale includes two subscales: Anxiety (HADS-A) and Depression (HADS-D). Each subscale ranges from 0 to 21, with higher scores indicating more severe symptoms.

Time frame
between inclusion (D0) and surgery (S0), occurring 1 to 3 months later.
2

Adaptive and maladaptive regulation

This outcomes is measured using the Cognitive Emotion Regulation Questionnaire (CERQ). Two composite scores are derived: adaptive regulation and maladaptive regulation. The adaptative regulation is measured using the Cognitive Emotion Regulation Questionnaire - Adaptive (CERQ-A) wich include five adaptive subscales . Scores range from 20 to 100, with higher scores indicating better adaptive regulation. The maldaptative regulation is measured using the Cognitive Emotion Regulation Questionnaire - Non-Adaptive (CERQ-NA) wich include four maladaptive subscales. Scores range from 16 to 80, with higher scores indicating greater use of maladaptive regulation strategies.

Time frame
between inclusion (D0) and surgery (S0), occurring 1 to 3 months later.
3

Catastrophizing

The outcome is measured using the Symptom Catastrophizing Scale (SCS), a 7-item questionnaire assessing catastrophic thinking related to symptoms. Total scores range from 0 to 14.

Time frame
between inclusion (D0) and surgery (S0), occurring 1 to 3 months later.
4

Use of additional supportive measures

The questionnaire is completed by the physician based on the prescription made or recommended to the patient. The questions are independent and do not generate a score.

Time frame
at the inclusion (D0)

Other outcomes

Sponsors and contacts

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