Effects of Parents Included in Medical Round of Neonatal Intensive Care Unit

NCT05717075 | Completed

• 1 other identifier: Parents round RCT
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this cross-over randomized controlled study is to evaluate the effects of medical rounds with parents. The main questions it aims to answer are:

• How feasible the protocol of this study is to include parents in the medical round?
• Does the Family Round promote the quality of family centered care in the NICU perceived by parents and healthcare staff?
• Does the Family Round promote parent-infant bonding?
• Does the Family Round reduce parents' anxiety?
• Does the Family Round increase parents' satisfaction?
• Does the Family Round improve staff's communication skills to integrate parents in the discussion of medical rounds? Participants will participate in the Family Round for two weeks, which is organized by healthcare staff following a protocol aiming to integrate parents into the discussion. They will be compared to the two-week period without the Family Round.

Conditions

Family Centered Care; Decision Making

Keywords

Medical round; Doctor's round

Outcome Measures

Primary Outcomes (4)

• Quality of family centered care assessed by parents

  The family centered care provided by the NICU is assessed by parents using FCC-Q, which was modified from DigFCC SMS questions. It consists of 9 questions: 1) active listening, 2) parent participation in infant care, 3) individualized parent education, 4) parent participation in decision-making, 5) the parental trust toward staff in infant care, 6) the parental feelings of the staff trust in infant care, 7) participation in medical round/medical care decision making, 8) received information, and 9) emotional support. The questionnaire for healthcare staff does not include question no. 7, about medical round/medical care decision making. Each question has the Likert scale from 1 to 7 (1 not at all and 7 very much; 0 if they did not visit the unit). The average score varies from 1 to 7 and a higher score indicates better family centered care received by parents.

  2 weeks

• Quality of family centered care assessed by parents

  The family centered care provided by the NICU is assessed by parents using FCC-Q, which was modified from DigFCC SMS questions. It consists of 9 questions: 1) active listening, 2) parent participation in infant care, 3) individualized parent education, 4) parent participation in decision-making, 5) the parental trust toward staff in infant care, 6) the parental feelings of the staff trust in infant care, 7) participation in medical round/medical care decision making, 8) received information, and 9) emotional support. The questionnaire for healthcare staff does not include question no. 7, about medical round/medical care decision making. Each question has the Likert scale from 1 to 7 (1 not at all and 7 very much; 0 if they did not visit the unit). The average score varies from 1 to 7 and a higher score indicates better family centered care received by parents.

  4 weeks

• Quality of family centered care assessed by healthcare staff

  The family centered care provided by the NICU is assessed by parents or healthcare staff using FCC-Q, which was modified from DigFCC SMS questions. It consists of 8 questions: 1) active listening, 2) parent participation in infant care, 3) individualized parent education, 4) parent participation in decision-making, 5) the parental trust toward staff in infant care, 6) the parental feelings of the staff trust in infant care, 7) received information, and 8) emotional support. The questionnaire for healthcare staff does not include question no. 7, about medical round/medical care decision making. Each question has the Likert scale from 1 to 7 (1 not at all and 7 very much; 0 if they did not visit the unit). The average score varies from 1 to 7 and a higher score indicates better family centered care received by parents.

  before the enrollment of the first patient

• Quality of family centered care assessed by healthcare staff

  The family centered care provided by the NICU is assessed by parents or healthcare staff using FCC-Q, which was modified from DigFCC SMS questions. It consists of 8 questions: 1) active listening, 2) parent participation in infant care, 3) individualized parent education, 4) parent participation in decision-making, 5) the parental trust toward staff in infant care, 6) the parental feelings of the staff trust in infant care, 7) received information, and 8) emotional support. The questionnaire for healthcare staff does not include question no. 7, about medical round/medical care decision making. Each question has the Likert scale from 1 to 7 (1 not at all and 7 very much; 0 if they did not visit the unit). The average score varies from 1 to 7 and a higher score indicates better family centered care received by parents.

  1 month after the end of the intervention of the last patient

Secondary Outcomes (11)

• Bonding feeling of parens toward their infant

  2 weeks

• Bonding feeling of parens toward their infant

  4 weeks

• Parents' anxiety

  2 weeks

• Parents' anxiety

  4 weeks

• Parents' satisfaction

  2 weeks

Study Arms (2)

Group A (Parents Round, then no special round)

OTHER

Parents of enrolled patient receive the intervention for two weeks after the consent to the study (Period I). For two weeks after the intervention in Period I, the parents do not receive the intervention (Period II).

Behavioral: Parents Round

Group B (no special round, then Parents Round)

OTHER

Parents of enrolled patient receive no intervention for two weeks after the consent to the study (Period I). For two weeks after Period I, the parents receive the intervention (Period II).

Behavioral: Parents Round

Interventions

Parents Round BEHAVIORAL

The intervention carried out in this study is called Family Round. The Family Round is an additional medical round, aiming to involve parents in the discussion. The basic attitude of the healthcare staff is to make decisions collaboratively with parents or other family members based on the parents' observations of their infant and parents' opinions. As our daily medical round is carried out in the morning between 8 and 10 a.m. and we offer no accommodation for parents in the NICU, the Family Round will be carried out separately in the afternoon. One neonatologist who is in charge of the infant or taking care of the infant on that day will be a facilitator and proceed with the Parent Round according to the protocol. Other healthcare staff are also encouraged to participate, although the number of participants is limited.

Group A (Parents Round, then no special round); Group B (no special round, then Parents Round)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Infants in the NICU and their parents/partner
• Infants who are expected to stay in the NICU for more than one month in the future at consent

Sponsors & Collaborators

• Nagano Children's Hospital: lead

Study Sites (1)

Nagano Children's Hospital

Azumino, Nagano, 399-8288, Japan

Location

Study Officials

• +81-263-73-6700 Itoshima, MD

  Nagano Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 8, 2023
• Study Start: March 5, 2023
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)