Satisfaction in women who have recently given birth receiving epidural analgesia after shared-decision making before the onset of labor
| ISRCTN | ISRCTN14256563 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14256563 |
| Secondary identifying numbers | IRB Serial No.: 10705-010 |
- Submission date
- 01/04/2020
- Registration date
- 15/04/2020
- Last edited
- 12/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
Epidural analgesia is the administration of opioids and/or local anesthetics into the epidural space. It is often administered during childbirth.
The clinical explanation of epidural analgesia by anesthesiologist would often begin after the pregnant mother (parturient) is admitted into the hospital. However, because of labor pain, the decision of receiving epidural analgesia would often be made by the companion of the parturient, such as the husband, instead of the parturient herself. The researchers believe that this situation should be remedied and thus conducted a study comparing the satisfaction and level of epidural analgesia comprehension in parturients receiving the routine procedure and those receiving a prenatal shared decision-making (SDM) intervention.
Who can participate?
Women who have recently given birth by natural spontaneous delivery who used epidural analgesia during the natural birth process
What does the study involve?
During their 28th week of gestation, the SDM group is given a health education leaflet with a QR code linking to health education videos that explain what epidural analgesia is and its advantages and disadvantages. After giving birth patients answer a questionnaire.
What are the possible benefits and risks of participating?
After the intervention, participation in decision-making may improve. There is no risk in participating in this trial.
Where is the study run from?
Chi Mei Medical Center (Taiwan)
When is the study starting and how long is it expected to run for?
June 2018 to December 2019
Who is funding the study?
This study was supported by Chi Mei Medical Center (Taiwan), under the grant CMFHR108110.
Who is the main contact?
Dr Ying-Jen Chang, 0201day@yahoo.com.tw
Contact information
Scientific
Department of Anesthesiology
Chi Mei Medical Center
901 Zhonghua Road
Yongkang District
Tainan
710
Taiwan
 ORCID ID |
0000-0002-4824-6216 |
|---|---|
| Phone | +886 62812811 |
| cmh7760@mail.chimei.org.tw |
Study information
| Study design | Interventional non-randomised before and after study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Before and after study design |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Evaluating the satisfaction in parturients receiving epidural analgesia after prenatal shared decision-making intervention |
| Study hypothesis | The satisfaction and level of epidural analgesia comprehension will improve in parturients receiving the routine procedure and those receiving a prenatal shared decision-making (SDM) intervention. |
| Ethics approval(s) | Approved DATE, Institutional Review Board of the Chi Mei Medical Center (901 Zhonghua Road, Yongkang District, Tainan, 701, Taiwan R.O.C.; +886-6-281-2811-53720; cmhirb@mail.chimei.org.tw), ref: 10705-010 |
| Condition | Epidural analgesia during childbirth |
| Intervention | During their 28th week of gestation, the shared decision making (SDM) group was given a health education leaflet with a QR code linking to health education videos that explained what epidural analgesia is and its advantages and disadvantages. A specific questionnaire in local language (Chinese)—designed to measure the satisfaction of labor pain relief, the degree of access to information, and the communication from health care staff—incorporated items from three health care communication questionnaires: Pregnancy and Maternity Care Patients’ Experiences Questionnaire (PreMaPEQ), Preterm Birth Experience and Satisfaction Scale (P-BESS), and Women’s Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ). |
| Intervention type | Behavioural |
| Primary outcome measure | Satisfaction measured using a novel questionnaire combining elements of Pregnancy and Maternity Care Patients’ Experiences Questionnaire (PreMaPEQ), Preterm Birth Experience and Satisfaction Scale (P-BESS), and Women’s Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ) after giving birth. |
| Secondary outcome measures | Comprehension of the consenting process measured using a novel questionnaire combining elements of Pregnancy and Maternity Care Patients’ Experiences Questionnaire (PreMaPEQ), Preterm Birth Experience and Satisfaction Scale (P-BESS), and Women’s Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ) after giving birth. |
| Overall study start date | 05/06/2018 |
| Overall study end date | 31/12/2019 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 200 |
| Total final enrolment | 200 |
| Participant inclusion criteria | Parturients after natural spontaneous delivery who have used epidural analgesia during the natural birth process |
| Participant exclusion criteria | 1. Mental disorders or emotional disorders, regardless of whether they are receiving psychiatric medication 2. Drug addiction or drug dependence (for example, those who have a history of drug use, or who have used morphine analgesics daily for more than 30 mg of oral morphine equivalent for more than six weeks) 3. Cannot read Chinese 4. In the intensive care unit after delivery |
| Recruitment start date | 14/06/2018 |
| Recruitment end date | 31/12/2019 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Yongkang District
Tainan
710
Taiwan
Sponsor information
Hospital/treatment centre
901 Zhonghua Road
Yongkang District
Tainan
710
Taiwan
| Phone | +886 62812811ext. 52652 |
|---|---|
| cmh8888@mail.chimei.org.tw | |
| Website | http://www.chimei.org.tw/main/cmh_department/54220/english/ |
"ROR" |
https://ror.org/02y2htg06 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Other non-profit organizations
- Location
- Taiwan
Results and Publications
| Intention to publish date | 01/08/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/07/2020 | 22/07/2020 | Yes | No |
| Dataset | The raw data of the 200 file-questionnaires. | 12/06/2023 | No | No |
Editorial Notes
12/06/2023: A link to a dataset was added.
22/07/2020: Publication reference and total final enrolment number added.
14/04/2020: Trial’s existence confirmed by Institutional Review Board of the Chi Mei Medical Center
