Use of Nitrous Oxide for Pain and Anxiety Management During Cervical Cerclage Removal
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorKaplan Medical Center
About this trial
The goal of this clinical trial is to determine whether inhaled nitrous oxide can reduce pain and anxiety during cervical cerclage removal compared with standard care. Cervical cerclage removal is commonly performed in the outpatient setting during the third trimester of pregnancy and may be associated with discomfort and anxiety despite being a brief procedure.
The study will include pregnant women aged 18 years or older undergoing elective cervical cerclage removal at 36 weeks of gestation or later.
The main questions the study aims to answer are:
* Does inhaled nitrous oxide reduce pain during cervical cerclage removal? * Does inhaled nitrous oxide reduce anxiety during the procedure? * Does the use of nitrous oxide improve overall patient satisfaction during cerclage removal?
Researchers will compare women receiving inhaled nitrous oxide to those receiving standard care without analgesia, as routinely practiced in the participating institutions, in order to determine whether nitrous oxide improves pain control and patient experience during the procedure.
Participants will:
* Be randomly assigned to receive either inhaled nitrous oxide (50% nitrous oxide / 50% oxygen) or standard care without analgesic treatment during cervical cerclage removal. * Undergo the procedure according to routine clinical practice in the participating centers. * Complete questionnaires assessing pain and anxiety, including a visual analog scale (VAS) for pain and the State-Trait Anxiety Inventory (STAI). * Have routine clinical data recorded from their medical records, including maternal vital signs and any procedure-related side effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Women at ≥34 weeks of gestation
Singleton or twin pregnancy
Ability to understand, sign informed consent, and complete questionnaires
Disqualifiers
Triplet or higher-order pregnancy
Contraindications to nitrous oxide use
Fetal monitoring category 2 or higher
Maternal body temperature >38°C
Trial design
Design model
Parallel
Treatments tested in this trial
Inhaled nitrous oxide
DrugInhaled nitrous oxide (50% nitrous oxide / 50% oxygen) administered via a demand-valve mask during cervical cerclage removal. The system includes a one-way valve and is self-administered by the patient, who holds the mask and inhales as needed. The device is identical to the equipment routinely used for labor analgesia in the participating institutions and is operated and monitored by trained midwives experienced in nitrous oxide administration. Nitrous oxide inhalation begins following instruction from the performing physician. The procedure starts approximately three minutes after inhalation begins, once adequate analgesia and anxiolysis are achieved. Continuous pulse oximetry monitoring is performed during administration. After completion of the procedure, nitrous oxide is discontinued and the patient breathes room air.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Inhaled Nitrous Oxide During Cervical Cerclage RemovalExperimental treatment 1 intervention
Group B: Standard Care Without AnalgesiaNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Pain intensity during cervical cerclage removal
Pain intensity will be assessed using a 0-100 mm visual analog scale (VAS). Participants will rate the level of pain experienced during the procedure 3-5 minutes after completion of the cerclage removal.
Time frame
3-5 minutes following completion of the procedureSecondary outcomes
1
Difference between expected pain and experienced pain
Expected and experienced pain will be assessed using a 0-100 mm Visual Analog Scale (VAS), where higher scores indicate greater pain intensity. The difference between expected and experienced pain scores will be calculated.
Time frame
Baseline (prior to procedure) and 3-5 minutes following completion of the procedure2
Procedure duration
Total duration of the cerclage removal procedure, measured in minutes from the beginning of the procedure to completion.
Time frame
During procedure3
Change in maternal heart rate during procedure
Difference (delta) between baseline maternal heart rate and the maximal heart rate recorded during the procedure
Time frame
Baseline measurement prior to the procedure and continuous monitoring during the procedure4
Change in anxiety level (STAI)
Anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI). The STAI score ranges from 20 to 80, with higher scores indicating higher levels of anxiety. Participants will complete the questionnaire before the procedure and again after cerclage removal. The change in STAI score will be analyzed.
Time frame
Baseline (before procedure) and 3-5 minutes after completion of the procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kaplan Medical Center
Lead sponsor
Clalit Health Services
Collaborator
Wolfson Medical Center
Collaborator
Rabin Medical Center
Collaborator
Meir Medical Center
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: