HysterectomyRELIEFNCT07430488
Effect of Reading a Personal Narrative Book on Emotional Regulation in Women of Childbearing Age Undergoing Hysterectomy (RELIEF)
A study testing personal narrative book in people with Hysterectomy and Anxiety, run by Groupe SantéCité SantéCité Enseignement-Recherche-Innovation (GCS SCERI) at 4 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Hysterectomy, Anxiety, Depression
- What is being tested?
- personal narrative book
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 4 sitesFrance
- Study dates
- 13 May 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
- Patients able to read and understand French and capable of reading a French book within a timeframe compatible with the study schedule
Who cannot join
- 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
- Patients with insufficient proficiency in the French language
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Clinique Tivoli-Ducos
Bordeaux, 33000
Dr. Adrien Crestani, 07 85 30 63 45, recherche@ifemendo.fr
- Recruiting
Clinique Charcot
Sainte-Foy-lès-Lyon, 69110
Dr. Nicolas Carrabin, 04 72 32 30 22, fse-carrabin@clinique-charcot.fr
- Recruiting
Clinique Pasteur Toulouse
Toulouse, 31076
Dr. Anne-Sophie Boudy, 05 62 21 39 54, asboudy@clinique-pasteur.com
- Recruiting
Clinique St Cyprien Rive Gauche
Toulouse, 31330
Dr. Jérome Capdet, 05 61 77 33 66, dr.capdet@clinique-rivegauche.fr
About this study
Official title: Effect of Reading a Personal Narrative Book on Emotional Regulation in Women of Childbearing Age Undergoing Hysterectomy: A Randomized Controlled Trial (RELIEF)
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:
Read more
- 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.
- Conditions
- Hysterectomy, Anxiety, Depression, Catastrophizing
- Being tested
- personal narrative book
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personal narrative bookOther
Reading a personal narrative book written by a patient who underwent a hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | CNGOF information leaflet with a consultation with a psychologist or other additional supportive measures if needed. |
| Intervention ("Personal Narrative" arm) | Experimental | CNGOF information leaflet, personal narrative book, and a consultation with a psychologist or other additional supportive measures if needed. Receives: Other: personal narrative book |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: between inclusion (D0) and surgery (S0), occurring 1 to 3 months later.
Secondary outcomes (6)
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.
Measured: between inclusion (D0) and surgery (S0), occurring 1 to 3 months later.
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.
Measured: between inclusion (D0) and surgery (S0), occurring 1 to 3 months later.
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.
Measured: between inclusion (D0) and surgery (S0), occurring 1 to 3 months later.
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.
Measured: at the inclusion (D0)
Use of additional supportive measures
The questionnaire is completed by the patient. The questions are independent and do not generate a score.
Measured: Postoperative, occuring 1 to 3 months after inclusion.
Patient satisfaction
The outcome is measured using the Likert-type satisfaction scale to determine satisfaction with their care. Responses range from "extremely satisfied" to "extremely dissatisfied."
Measured: Postoperative, occuring 1 to 3 months after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start13 May 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe SantéCité SantéCité Enseignement-Recherche-Innovation (GCS SCERI)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430488
- Sponsor's protocol ID
- SCERI_2025_RIPH2_2025-01
- Acronym
- RELIEF
- Status last verified
- Jul 2026
- First submitted
- 19 Jan 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Reading a Personal Narrative Book on Emotional Regulation in Women of Childbearing Age Undergoing Hysterectomy: A Randomized Controlled Trial (RELIEF)
- ClinicalTrials.gov ID
- NCT07430488
- Acronym / sponsor ID
- RELIEF / SCERI_2025_RIPH2_2025-01
- Conditions
- Hysterectomy, Anxiety, Depression, Catastrophizing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Groupe SantéCité SantéCité Enseignement-Recherche-Innovation (GCS SCERI)University, hospital or other
- Study start
- 13 May 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –CNGOF information leaflet with a consultation with a psychologist or other additional supportive measures if needed. |
| Intervention ("Personal Narrative" arm) | Experimental | Other: personal narrative bookCNGOF information leaflet, personal narrative book, and a consultation with a psychologist or other additional supportive measures if needed. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
- Patients able to read and understand French and capable of reading a French book within a timeframe compatible with the study schedule
Key exclusion criteria (5 listed)
- 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
- Patients with insufficient proficiency in the French language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| personal narrative bookReading a personal narrative book written by a patient who underwent a hysterectomy | Other | Intervention ("Personal Narrative" arm) |
Primary outcome
Adaptive regulation
Time frame: between inclusion (D0) and surgery (S0), occurring 1 to 3 months later.
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.
6 secondary outcomes
Anxiety and depression
Time frame: between inclusion (D0) and surgery (S0), occurring 1 to 3 months later.
Adaptive and maladaptive regulation
Time frame: between inclusion (D0) and surgery (S0), occurring 1 to 3 months later.
Catastrophizing
Time frame: between inclusion (D0) and surgery (S0), occurring 1 to 3 months later.
Use of additional supportive measures
Time frame: at the inclusion (D0)
Use of additional supportive measures
Time frame: Postoperative, occuring 1 to 3 months after inclusion.
Patient satisfaction
Time frame: Postoperative, occuring 1 to 3 months after inclusion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personal narrative book in people with Hysterectomy and Anxiety, run by Groupe SantéCité SantéCité Enseignement-Recherche-Innovation (GCS SCERI) at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adaptive regulation (time frame: between inclusion (D0) and surgery (S0), occurring 1 to 3 months later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.