Recording by Patients and Relatives/Friends in the Maternity Unit

Completed

• Conditions: Health Personnel Attitude; Knowledge, Attitudes, Practice; Maternity; Healthy
• Interventions: Other: Non-interventional study

• Registration Number: NCT04272905
• Lead Sponsor: Chelsea and Westminster NHS Foundation Trust

Brief Summary

Increasingly, patients are keen to record aspects of their medical care, especially in obstetrics and paediatrics. The knowledge of patients and staff in relation to this area is thought to be variable. In addition, the attitudes of patients and staff regarding this practice has not been well studied. This study aims to gather information on patients' use of recording devices to capture audio recordings, photographs or videos. Furthermore it aims to assess patient and staff knowledge and attitudes in relation to this area.

This study will involve patients who have recently delivered a baby on the maternity unit or obstetric theatre completing a questionnaire. They will be approached by a study investigator and the study explained. They will then complete a consent form if they are happy to proceed. Following this they will complete the questionnaire.

It will also involve the surveying of staff, who will be approached by a study investigator when not directly involved in the clinical care of patients. They will also complete a consent form if they are happy to proceed and then complete the questionnaire.

Detailed Description

The aim of the study is to evaluate the knowledge and attitudes of both patients and staff towards the recording by patients/relatives/friends within the obstetric environment.

Study Timeline

• Study Start: 2019-07-05
• Primary Completion: 2019-11-12
• Study Completion: 2019-12-18
• Status Verified: 2020-02
• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-14
• Last Update Submitted: 2020-02-14
• Study First Posted: 2020-02-17
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• > 18 years
• Post natal following any form of delivery
• Between 4 and 48 hours after delivery
• Able to understand English adequately to give consent and complete the questionnaire

Exclusion Criteria

• Women experiencing complications affecting themselves or their babies will be excluded if it is felt that approaching them for potential recruitment might be overly intrusive.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Maternity Unit Staff	Non-interventional study	* Doctors, midwives and other staff * Work on labour ward
Maternity patients	Non-interventional study	* \> 18 years * Post-natal following any form of delivery * Between 4 and 48 hours after delivery * Able to understand English adequately to give consent and complete the questionnaire

Primary Outcome Measures

Name	Time	Method
Knowledge and attitudes of both patients and staff towards the recording by patients/relatives/friends within the maternity unit and obstetric theatre environment.	Cross-sectional design: Participants are expected to be in the study for 15 minutes approx.	Staff and patients will be asked to complete an unvalidated questionnaire titled "Recording by patients and relatives/friends in the maternity unit", which is expected to take 10-15 minutes to complete. Please note that one questionnaire has been adapted for patients and another one for staff. Both contain 4 sections. The sections in the patients' questionnaire are: Background, Your experience of recording, Guidelines on recording and Your opinions regarding recording. The sections in the staff's questionnaire are: Background, Your experience of recording, Knowledge and Attitudes.; Data will be presented using descriptive statistics: Number (%) ± 95% CI for nominal data and median (IQR \[range\]) for ordinal data as appropriate.

Secondary Outcome Measures

Name	Time	Method
Group differences between the knowledge and attitudes of patients and staff regarding what is acceptable to record and appropriate uses of recordings.	Data analysis will be completed and reported within an average of one year.	Analytic statistics will be performed to compare differences in the results of the unvalidated questionnaire between the two groups (patients and staff) using the chi-squared/Fisher's exact test for nominal data and Mann-Whitney U-test for ordinal data, taking p \< 0.05 to denote statistical significance.

Trial Locations

Locations (1)

Chelsea and Westminster Hospital; 🇬🇧 London, Greater London, United Kingdom