Effekten av fars tilstedeværelse i operasjonssalen på kvaliteten av rekonvalesens hos fødende kvinner
Effekten av fars tilstedeværelse under elektiv keisersnitt under spinalanestesi på fødende kvinnes kvalitet av rekonvalesens
The presence of a partner to support the mother during cesarean and vaginal deliveries is a well-established practice in most countries worldwide. It is evident that allowing the partner into the operating room during a cesarean section provides psychosocial benefits for both the mother and the partner. This study aims to investigate the effect of the presence of partner in the operating room on quality of recovery of parturients at the postoperative period.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This prospective study evaluates the impact of the partner's presence in the operating room during elective cesarean sections on maternal anxiety, postoperative recovery, and surgeon stress levels. Patients are allocated into two groups: Partner Present and Partner Absent. Primary outcome is obstetric quality of recovery scale (ObsQoR 10) at the postoperative first day. Secondary outcomes include maternal pain (assessed via VAS at 6-hour intervals for the first 24 hours) and anxiety levels (STAI-T/S administered to couples preoperatively and STAI-S postoperatively) and ObsQoR-10 that will be evaluated at the postoperative 3rd and 7th days.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Karaman, Tyrkia (Türkiye), 70200
- Karaman Training and Research Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patients scheduled for an elective cesarean section.
- Patients and their partners must be literate in Turkish (able to read and write) to accurately complete the study questionnaires
- Patients and their partners must be willing and able to provide written informed consent
- Healthy pregnant women with no additional chronic or systemic diseases (comorbidities)
- The operating surgeon must have at least 5 years of professional experience and no chronic health conditions.
Exclusion Criteria:
- Patients undergoing emergency cesarean sections.
- Patients with any known chronic or systemic additional diseases
- Surgeons with any known chronic or systemic diseases.
- Individuals unable to read or understand the Turkish questionnaires (implied by the literacy requirement).
- Patients with American Society of Anesthesiologists (ASA) classification of 3 or more
- Patients with history of chronic pain, chronic use of analgesic drugs, or history of opioid or intravenous drug abuse
- Patients who have refused spinal anesthesia, or those in whom it is contraindicated.
- Pregnancy with preeclampsia or eclampsia
- Pregnancy with gestational diabetes mellitus or diabetes mellitus
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Partner til stede
|
The patient's partner is admitted to the operating room after sterile preparations are complete. The partner remains with the patient to provide physical and emotional support during the cesarean section operation |
|
Aktiv komparator: Partner fraværende
|
The patient undergoes the elective cesarean section according to standard hospital protocols. The partner is not present in the operating room during the surgery. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Obstetric Quality of Recovery-10 (ObsQoR-10) Score
Tidsramme: Post-operative 24th hour,
|
The ObsQoR-10 questionnaire will be used to assess the quality of maternal recovery after the cesarean section. The scale consists of 10 items, where patients rate each item from 0 (never) to 10 (always). Higher scores indicate a better quality of recovery. |
Post-operative 24th hour,
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Surgeon's Physiological Stress Level (Heart Rate)
Tidsramme: Intra-operative (during the entire duration of the cesarean section)
|
The operating surgeon's heart rate variability will be recorded using a rhythm Holter device during the surgery. A heart rate exceeding 100 beats per minute (bpm) will be considered an indicator of increased stress. |
Intra-operative (during the entire duration of the cesarean section)
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Maternal and Partner Anxiety Levels (STAI-T and STAI-S)
Tidsramme: Pre-operative and Post-operative (within the first 6 hours)
|
The State-Trait Anxiety Inventory (STAI) will be used to measure the patient's and partner's anxiety levels. Both the Trait (STAI-T) and State (STAI-S) components will be administered. Scores range from 20 to 80, with higher scores indicating greater anxiety. |
Pre-operative and Post-operative (within the first 6 hours)
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- faruk
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- E-11095095-050.04-253322
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