Table 1.

Included randomised controlled trials (RCTs)

RCT by publication year
Author (date), country	Parents’ gender/ sample size	Infants’ gestation age in weeks/NICU level	Study design	Intervention	Outcome measures	Timing of measurement	Method of measurement	Results	Parent co-design?	Improved parent satisfaction?
1. Northrup et al (2016), USA	Mothers and fathers /116	<28/level III	RCT	Intervention: free parking. Parents received seven parking vouchers at a time (value: US$10 each) and continued to receive vouchers until infant discharge. Each voucher allowed free entry and exit for 24 hours. Control: parents received the standard care and did not receive vouchers.	Parent satisfaction with NICU care.	After babies were discharged (once) During the first high-risk infant clinic visit after discharge. No preintervention parent satisfaction data available for comparison.	Satisfaction questionnaire Validation: no content validity or reliability testing reported. Eleven questions: Seven items were summed (score 7–35) to measure ‘support’ (eg, information sharing). Three items measured ‘emotional connection’ to the infant (score 3–15). One item assessed ‘family involvement in infant care’ (responses: not enough, just right, too much). Greater scores indicated higher perceived support, connection and satisfaction.	The groups did not differ significantly with respect to satisfaction. Intervention Control P value NICU support Mean (SD) 30 (2.7) 28.7 (3.7) 0.07 Emotional connection 12.3 (1.7) 12.3 (1.7) 0.96 Family involvement ‘Just right’ 81.4%–85% 0.07	No	2
2. Abdel-Latif et al (2015), Australia	Mothers and fathers /63	25–42/level III	Cross-over RCT	Intervention: parental Presence at Clinical Bedside Rounds (PPCBR). Parents attended bedside clinical rounds. Parents had opportunity to ask questions about their baby’s condition and management. Control: parents received the standard care with no parental presence at bedside clinical rounds.	Parent satisfaction assessed by questions of three domains: 1. Knowledge and understanding. 2. Communication and collaboration. 3. Privacy and confidentiality.	During babies’ admission (once): At the end of each study arm, separated by a washout period. No preintervention parent satisfaction data available for comparison.	Satisfaction questionnaire The authors stated ‘the research team designed the questionnaire’. Validation: no content validity or reliability testing reported. Number and format of questions: not stated.	PPCBR had significantly higher adjusted mean (95% CI) scores for some questions from domains 1 and 2. Domain 3 was comparable between the two study groups. Intervention Control p-value Domain 1 question: “I have received adequate information about my baby’s condition and management” Mean 4.321 3.947 0.03 Domain 2 questions: “In the last week I have been able to communicate effectively with my baby’s healthcare team” Mean 4.407 4.250 0.05 “In the last week I have collaborated with my baby’s healthcare team in the planning of care for my baby” Mean 3.843 3.426 0.02 “In the last week I have been able to ask the healthcare team questions about my baby’s care” Mean 4.642 4.259 0.004	No	1
3. Bastani et al (2015), Iran	Mothers /100	30–37 Mean (SD) Control: 33.90 (2.33) Intervention: 34 (1.9) /level not stated	RCT (block randomisation)	Intervention: family centred care (FCC). Mothers allowed access to their baby at any time, participated in the care process and were provided with information about neonatal care. Control: mothers received the standard care where they were only allowed to be present at the time of the infant’s entry to the NICU, and were only routinely informed.	Maternal satisfaction relating to three themes: Parental presence. Participation in neonatal care. Information about neonatal care.	During babies’ admission (twice): 24 hours after admission. At the time of discharge.	Satisfaction questionnaire (validated) A modified satisfaction questionnaire was used, based on a parental satisfaction instrument developed for measuring satisfaction in paediatric intensive care units. 18 questions Graded 0 (very dissatisfied) to 4 (very satisfied). The overall satisfaction rate was classified based on the mean scores (score <50%, between 75%–50% and >75%).	In the FCC group, preintervention and postintervention difference in maternal satisfaction was statistically significant p<0.001. Intervention Control P value Mean (SD) At 24 hours 22.36 (8.90) 22.06 (9.77) 0.87 At discharge 59.28 (6.86) 30.18 (14.09)<0.01	Unclear Mothers determined the reliability of the satisfaction tool and approved the educational pamphlet. Authors did not report if mothers had direct input in the intervention design.	1
4. Clarke-Pounder et al (2015), USA	Mothers and fathers /19 families	23–39/level III	RCT	Intervention: sharing information obtained from parent interviews with the primary NICU provider. Parents interviewed using the NICU- adapted Decision-Making Tool (N-DMT). Information obtained was placed in the electronic medical record (EMR) and shared with the primary neonatal provider via email. Daily rounds on all infants were audio-recorded for 3 days after enrolment to see if information from the N-DMT was incorporated into daily care planning. Control: the content of a recent social work note was communicated with the primary provider via email, creating an attentional control group.	Parent satisfaction with care.	During babies’ admission (once): 2 weeks after study entry. No preintervention parent satisfaction data available for comparison.	Satisfaction questionnaire An N-DMT-specific questionnaire was used. Validation: partially reported. Authors stated reliability testing took place; no information on content validity provided. Eight questions: for example,‘‘My baby’s doctors considered my goals and hopes for my baby during decision-making’’. Likert scale (1 strongly agree–4 strongly disagree). Total N-DMT score range 8–32.	There was no significant difference in satisfaction with care as measured by the N-DMT scale between the control group and intervention groups in a univariable model or multiple variable model controlling for gestational age. Intervention Control Median (range) 26 (15–28) 28.8 (19–32) No P value reported. There was, however, a pattern of decreased satisfaction with care among the intervention group compared with the control group across the N-DMT-specific survey questions, although the differences were not statistically significant.	Yes Information obtained from parents using the N-DMT was placed in the EMR and shared with the primary NICU provider via email (forming the intervention).	2
5. Holditch-Davis et al (2013), USA	Mothers /208	Preterm infants Mean (SD) Overall group 27.2 (3.0) /4 centres, levels II–III	RCT three groups (two intervention and one control) Postintervention testing only	Interventions: 1. Mothers were taught how to massage infants with auditory, tactile, visual and vestibular stimulation. 2. Kangaroo care. Control: attention control group. Mothers spent a similar amount of time with the study nurse discussing the equipment needed for preterm infant care at home. Study nurses provided education and support for all three groups. Mothers were not prevented from engaging in interventions of the other groups but did not receive formal education from the study nurse on the other interventions.	Parent (mother) satisfaction with the intervention. Satisfaction with the helpfulness of the study nurse. Whether the mother would recommend the study to others and the degree of change in the mother as a person and as a mother as a result of being in the study.	During admission period and postdischarge: At the time of discharge. At 2 months corrected age. No preintervention parent satisfaction data available for comparison.	Satisfaction questionnaire The questionnaire was designed by the study team. Validation: partially reported. Authors stated reliability testing took place; no information on content validity provided. 26 questions: relating to three dimensions of satisfaction: efficacy, caring and technical quality. Likert (1 least satisfied–5 most satisfied).	No significant differences occurred between the groups. Mothers in all three groups were satisfied with the intervention (mean scores of 3.3 or higher on a 5-point scale) and the helpfulness of the nurse (mean scores of 4.6 or higher on a 5-point scale).	No	2
6. Franck et al (2011), UK	Mothers and fathers /169	Mean (SD) Control: 31.94 (5.17) Interv: 29.40 (3.17) /4 centres, level III	Cluster RCT	Intervention: increasing parental involvement in infant pain management in the NICU. Parents received a booklet providing evidence-based information about pain and comforting infants in the NICU setting. Parents received two visits from a research nurse showing them how to apply the comforting techniques described in the booklet. Control: as part of usual care, parents in both the intervention and control groups received a detailed booklet with generic information about NICU care. Parents in the control group also received two visits from a research nurse listening to what parents had to say about their NICU experience (attention placebo).	At baseline: Parent satisfaction with NICU care. One week after the intervention: Satisfaction with information about pain control. Satisfied nurses make infant comfortable. Satisfied pain medicines help infant.	During babies’ admission (twice): At baseline (within 3–7 days of admission). 1 week after the intervention.	Individual questions Validation: no content validity or reliability testing reported. 1. At baseline: parent satisfaction was measured by one question: ‘satisfaction with NICU care’ (1 very satisfied–6 very unsatisfied) as part of the baseline parent characteristics questionnaire. 2. One week after the intervention: Three questions using the word ‘satisfied’ were selected from the validated Parent Attitudes About Infant Nociception survey (Likert scale 1 very satisfied–6 very unsatisfied).	At baseline: there was no significant difference in satisfaction between intervention and control group. Intervention Control Mean 1.45 (0.71) 1.51 (0.76) (SD) P value missing 1 week after the intervention: intervention parents were more satisfied with the information about pain control received than control parents. Intervention Control Mean 2.10 (0.97) 3.28 (1.27) (SD) P value<0.001	Yes The booklet was reviewed by 12 parents of infants who had been cared for in NICUs in the UK.	1
7. Livingston et al (2009), USA	Mothers /12	Mean (SD) Control: 33.4 (6.4) Intervention: 38.5 (3.1) /level III	RCT	Intervention: touch and massage. Mothers attended a 1 hour massage class taught by a nurse certified infant massage instructor (CIMI) and were asked to participate in at least three bedside massage instruction sessions taught within the next week. Infants received massage for seven consecutive days, from the mother or a CIMI. The touch procedure lasted 20 min. Control: infants received all usual hospital services including medical care, physical and occupational therapy services and developmentally supportive nursing care.	Caregiver (mother) satisfaction with their infant’s care. Caregiver satisfaction with the neonatal unit and the massage therapist.	During babies’ admission (three times): At baseline On completing the 7 day massage programme. 1 month following intervention.	Satisfaction questionnaire Two questionnaires were developed by the research team. Validation: no content validity or reliability testing reported. First questionnaire (at baseline): a brief self-report questionnaire about caregiver satisfaction with their infant’s care until that moment. No further details reported. Second questionnaire (on completing the 7-day massage programme and 1 month following intervention): a 10 min satisfaction questionnaire relating to infant’s response and caregiver satisfaction with the neonatal unit and the massage therapist. Number of questions: not stated. Likert scale (1 very dissatisfied–4 very satisfied). Sample statements: “How satisfied do you feel giving massage to your infant?”; “I feel that massage improved my infant’s hospital stay”.	It is unclear in the report if specific between-group comparisons and statistical analysis were conducted. At baseline and day 7: All caregivers were highly satisfied with the medical treatment their infant received. At day 7 and 1 month follow-up: All caregivers participating in the massage group reported high levels of satisfaction regarding their relationship with their infant and the massage programme’s impact on that relationship. Slight improvements in satisfaction regarding time the caregiver spent with the infant and involvement in the infant’s care were observed between day 7 and the 1 month follow-up (no further information reported).	No	3
8. Koh et al (2007), Australia	Mothers /200	Not stated/not stated	RCT	Intervention: provision of taped conversations with neonatologists to mothers. The initial conversation and subsequent conversations of significance with a neonatologist were taped and analysed (for both groups). Mothers received a tape of each conversation and a tape recorder. Control: usual care. Mothers were not given the tape or recorder.	Satisfaction with conversations held with the neonatologist. Satisfaction with the tape.	During admission period and postdischarge: At 10 days. At 4 months. At 12 months. No preintervention parent satisfaction data available for comparison.	Individual questions and a satisfaction scale Validation: no content validity or reliability testing reported. Number of questions: not stated. Likert scale (1–5 most satisfied) Questions related to: satisfaction with amount and quality of information presented, doctors’ communication skills, patient’s participation in the conversation. A satisfaction scale was used to assess: satisfaction with the tape.	No differences were found between the two groups in satisfaction with conversations. Mothers of babies with a poor outcome in the tape group were, however, significantly more satisfied with the conversations: Intervention Control Mean (95% CI) 115 (104–123.2) 100.5 (94.1–109.4) P value 0.0051 Most (71%–92%) of the mothers given the tapes stated that they helped their understanding, reminded them of what had been said, and helped their family to understand and recall information.	No	1
9. Mitchell-DiCenso et al (1996), Canada	Mothers and fathers/ 482	Mean (SD) Intervention: 35.1 (4.5) Control: 35 (4.3) /level III	RCT	Intervention: clinical nurse specialist/neonatal practitioner team (CNS/NP) care. Infants of intervention parents were assigned to be cared for by the CNS/NP team during the day and by paediatric residents during the night. Control: paediatric residents cared for infants of control parents around the clock. Neonatologists supervised both teams.	Parent satisfaction with care.	During admission period and postdischarge (twice): On fifth day after admission (full survey). After discharge over the phone (only questions related to satisfaction with discharge process). No preintervention parent satisfaction data available for comparison.	Satisfaction questionnaire (validated) The study team developed and used the validated NIPS questionnaire. Number of questions: not stated. NIPS score range (27–189); higher scores indicating greater satisfaction with care.	No statistically significant difference between groups. Intervention Control P value NIPS 140 139 0.67 Mean Difference in means 1.0, 95% CI (−3.6 to 5.6)	No	2
10. Broyles et al (1992), USA	Mothers /25	Mean (SD) Control: 34 (4) Intervention: 33.4 (4) /level III	RCT	Intervention: Detailed consent. Mothers were given information about mechanical ventilation. Detailed risk/benefit disclosure was provided both verbally and in writing. Control: mothers were given a brief verbal description about mechanical ventilation supplemented with detailed verbal and written disclosure if desired by them (flexible consent).	Maternal satisfaction with the information provided about mechanical ventilation.	During babies’ admission (once): 24–48 hours after the intervention No preintervention parent satisfaction data available for comparison.	An interview evaluating maternal satisfaction with the information provided about mechanical ventilation. Validation: a psychiatrist with a special interest in interviewing techniques was consulted in designing and standardising this assessment. A research nurse conducted the interview, ‘checking’ each mother against one option regarding: Amount of information: Right amount–too much–too little. Information made coping: more difficult–easier–no effect–uncertain.	This study is measuring and comparing satisfaction with two different interventions (detailed vs flexible consent process), neither of which formally represent the usual routine care for all babies (no control). Small numbers. No data indicating statistical analysis conducted or evidence of statistically significant results. Detailed Flexible Right 75% mothers 100% amount of information Too 25% mothers little information Made 67% mothers 69% coping easier	No	3

NICU, neonatal intensive care unit; NIPS, Neonatal Index of Parent Satisfaction.