UMIN-ICDS Clinical Trial

Public title

Questionnaire survey regarding labor anesthesia

Acronym

Questionnaire survey regarding labor anesthesia

Scientific Title

Questionnaire survey regarding labor anesthesia

Scientific Title:Acronym

Questionnaire survey regarding labor anesthesia

Region

Japan

Condition

pregnancy

Classification by specialty

Obstetrics and Gynecology	Anesthesiology	Nursing

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Since 2017, the hospital has been offering pain-free delivery by epidural or spinal subarachnoid anesthesia to pregnant women who wish to do so. In daily clinical practice, after delivery, ward midwives conduct a review of the delivery, but this review of the experience of painless delivery is not mandatory, and many patients are not able to evaluate their satisfaction with the painless delivery provided by the Department of Anesthesiology. In addition to pain control, it is necessary to establish good communication with the anesthesiology staff and to care for the pregnant and nursing mother so that she can make decisions. To provide more patient-oriented medical care in the future, we believe it is necessary to survey the level of satisfaction with the painless deliveries provided by the anesthesiology department at our hospital.

Basic objectives2

Others

Basic objectives -Others

To identify patient satisfaction in labor anesthesia using objective indices.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

patient satisfaction

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

60

years-old

>=

Gender

Female

Key inclusion criteria

1) Women who had a anesthesia labor at St. Luke's International Hospital (including cases who had a cesarean section during a anesthesia labor)
2) People who can read and write Japanese

Key exclusion criteria

1) Delivery due to intrauterine fetal death.
2) Delivery due to abortion.
3) Severe complications of delivery in the newborn or the mother.
4) Suspicion of any disease in the newborn.
5) The principal investigator or co-investigators determines that the subject is inappropriate for the study.

Target sample size

1000

Name of lead principal investigator

1st name	kameda
Middle name
Last name	megumi

Organization

St. Luke's International Hospital

Division name

Anesthesiology

Zip code

104-8560

Address

9-1 Akashicho, Chuo-ku, Tokyo

TEL

03-3541-5151

Email

kameg@luke.ac.jp

Name of contact person

1st name	kameda
Middle name
Last name	megumi

Organization

St. Luke's International Hospital

Division name

Anesthesiology

Zip code

104-8560

Address

9-1 Akashicho, Chuo-ku, Tokyo

TEL

03-3541-5151

Homepage URL

Email

kameg@luke.ac.jp

Institute

St. Luke's International University

Institute

Department

Personal name

Organization

St. Luke's International University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

St. Luke's International University

Address

10-1 Akashicho, Chuo-ku, Tokyo

Tel

03-3543-6391

Email

kameg@luke.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

02

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2024

Year

02

Month

01

Day

Date of IRB

Anticipated trial start date

2024

Year

02

Month

01

Day

Last follow-up date

2026

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Method of recruitment of subjects: All patients who delivered at our facility between March 1, 2024, and March 31, 2025 (expected) met the selection criteria.
Items to be measured: Patients will be asked to score 1-10 on each of the following items.
Anxiety about the pain of labor before labor begins.
Satisfaction with the explanation at the obstetric anesthesia outpatient department.
Satisfaction with anesthesia labor in LDR
Satisfaction with anesthesia labor.
Did you have good communication with the anesthesiology staff during the anesthesia labor?
Satisfaction with pain during labor after anesthesia.
Did you feel your will was respected during the anesthesia labor?
Satisfaction with anesthesia during cesarean section after initiation of anesthesia labor.
Satisfaction with anesthesia during cesarean section.
Did you have good communication with the anesthesiology staff during the cesarean section.
Satisfaction with pain during cesarean section.
Did you feel that your will was respected during the cesarean section?

Registered date

2024

Year

01

Month

24

Day

Last modified on

2024

Year

01

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060727