Study setting
This study is a prospective randomized controlled trial (RCT). This study was conducted from July 1, 2020, to July 1, 2021, and included all live-born premature infants and their mothers who were admitted to a 50-bed tertiary neonatal intensive care unit and who received care within 24 h of birth.
Participants (mother–infant pairs)
The inclusion criteria were as follows: (1) preterm infant with a gestational age of less than 32 weeks or birth weight less than 1500 g; (2) the infant was estimated to be hospitalized in the NICU for at least two weeks after recruitment; (3) the mother was the primary caregiver and ≥18 years old; (4) the mother was willing to participate in and was available for KMC for two weeks after recruitment.
The exclusion criteria were as follows: (1) birth complicated with severe fatal disabling congenital chromosomal abnormalities or malformation; (2) severe congenital heart disease; (3) the mother was diagnosed with a mental disorder; (4) the mother had a history of substance abuse or addiction; (5) the mother suffered complications during pregnancy or delivery or was otherwise ill and had not yet recovered at the time of recruitment.
The withdrawal criteria were as follows: (1) the guardian’s required discharge against medical advice during hospitalization; (2) the infant’s medical condition deteriorated suddenly and potentially threatened life during KMC.
Recruitment
Guardians of all preterm infants admitted to our NICU are reminded by the nurse in advance by being given a leaflet to learn about KMC for their babies. Once the medical condition of the preterm infant improved and the need for KMC was confirmed during hospitalization, one of the three researchers, including the principal investigator (PI) and the other two neonatology fellows, immediately communicated with the mother about recruitment. The three researchers worked in the NICU and had a schedule to ensure that at least one was available. They were responsible for recruiting participants through eligibility assessment and explaining adequate information about the research to mothers following the ongoing study. Informed consent was obtained from the mother and infant’s legal guardian before they participated in the study.
The mother received a photo album as a souvenir that recorded the photos taken during KMC and mindfulness training from the funding. However, financing cannot account for part of the hospitalization costs of preterm infants, and each mother was responsible for the cost of travelling to and from the hospital.
Study groups and blinding
All the mothers who participated in the study were separated into a control group and an intervention group using a random number table by the appointed persons. The two nursing supervisors participated in “allocation concealment”, which did not involve recruiting participants and subsequent clinical work. First, one nursing supervisor compiled the allocation sequence table (the first column was the serial number of the recruited participant, the second column was the random number, and the third column was the group identification). Second, a computer was used to generate a random number sequence. In advance, the other nursing supervisor assigned odd numbers to the intervention group and even numbers to the control group. Third, each participant was given a unique computer-generated random number in sequence one by one and was assigned to the relevant group. Finally, the three copies of the allocation sequence table (one each for the two nursing supervisors and the PI) were sealed in an opaque envelope and locked away.
Given the nature of the intervention, it was impossible to blind the participants, investigators, and nurses. The statistician who evaluated the outcome was blinded. Each mother was individually informed not to disclose or share intervention details with other mothers during recruitment.
Experimental design and quality improvement policy
(1) In the control group, KMC was allowed when the medical condition of the preterm infant was stable (the respiratory rate and transcutaneous oxygen saturation remained normal without respiratory support or only required a low concentration of additional oxygen or lower parameter noninvasive assisted ventilation, and the blood pressure remained normal without vasoactive drugs and exhibited homeostasis). The charge nurse of the infant called his mother and informed her regarding the following: (1) arrangements with the mother about the “KMC schedule” that was convenient for her and the medical staff; (2) provision of the quick response (QR) code of the official account containing KMC guidelines and video tutorials to the mother; and (3) reminding of the mother about precautions in the process of KMC and advisement to practice KMC on the baby doll at home in advance. The mother arrived at the hospital at the appointed time, wiped her upper body skin with a warm towel in the bathroom (in China, there is a tradition for a puerpera to avoid bathing in water and catching a cold during confinement; “Zuo-yue-zi”), put on a special soft robe with the open front style, put on a medical mask and cap, and cleaned her hands thoroughly, then entered the ward and sat in a lounge chair next to her infant’s incubator. The charge nurse positioned the infant and let his mother have skin-to-skin contact with him, then stayed with them and explained to the mother how to observe the infant and which actions to perform. The mother wore a wireless noise-cancelling headset equipped with a microphone before KMC and listened to light music through an external electronic device. The treatment course of KMC is 1 h per day, lasting for 14 days.
(2) In the intervention group, similar to the control group, in addition to receiving KMC, mindfulness training was also arranged for the mothers. Mindfulness training was administered 15 min after the KMC began, lasting for 30 min, followed by 15 min of light music and ending simultaneously with the KMC.
In the preparation stage of the study, the mindfulness training protocol based on the MBSR program was developed through multiple discussions and revisions by a mindfulness instructor who obtained the formal “certified to teach MBSR” qualifications, with the assistance of two neonatologists and two charge nurses. The training protocol consisted of 14 professional training sections and four specific scenarios set up in advance: 1 section for an introduction to mindfulness; 13 sections for mindfulness basics, including the themes of arriving in presence, conscious relaxing, returning to one’s senses, the attitude of friendliness, mindfulness of breath, calming and steadying with the breath, counting the breath, deepening the focus, mindfulness of the body, feeling from the inside out, body scan, naming sensations, and working with intense sensations. They are all stored in the form of audio and manuscripts.
We conducted a 7-day training for the nurses, with 4 h of training each day divided into 2-hour sessions in the morning and afternoon. The training covered a total of 14 themes, with each theme including a 30-minute “Theoretical Teaching”, a 30-minute “Leading the experience”, a 30-minute “Discussion and sharing”, and a final 30-minute “Q&A and Recap”. The content of the themes is consistent with the 14 themes of audio playback in Fig. 1. On the last day of training, after all the course studies were completed, a live assessment was conducted. The nurses receiving the training sat together, and the mindfulness instructor posed a question: What kind of challenges do you think the mothers of preterm infants who are hospitalized in the NICU may encounter? Please describe possible scenarios or situations. After brainstorming, the mindfulness instructor selected four of the most common scenarios and asked: How should mothers respond to the abovementioned situations? On the basis of their 7-day training, the nurses proposed their own ways of coping. The mindfulness instructor guided and deepened the discussion on the basis of the results from the nurses’ conversations, ultimately forming a relatively procedural solution together. The four most specific scenarios were as follows: (1) After birth, the baby was placed on the baby radiation rescue desk. He was small, like a kitten, with a purple face and lips. Several doctors surrounded him for rescue and then transferred him to the NICU with a transport incubator. (2) The baby was hospitalized alone in the NICU with a ventilator to help breathe and various infusion tubes to provide nutrients, surrounded by the alarm sounds of various monitoring instruments. (3) To ensure that the baby has a continuous supply of breast milk in the NICU, the mother must use a breast pump instead of feeding alone. Collecting breast milk is her first task after waking up and her last task before going to bed. (4) This mother looks at the stretch marks on her relaxed belly after giving birth, thinking about when her child would be able to return to her side. Her husband worked during the day and was too tired at night to comfort her. After quarrelling again and again, she often cried silently, feeling that he no longer loved her.
The nurse-assisted mindfulness training schedule
The nurse and mother both wore wireless noise-cancelling headphones equipped with a microphone, and they could listen to the same audio and talk to each other in real time via a preset external computer. First, they listened to light music for 15 min, and then mindfulness training began. The nurse sat next to the mother, explaining the instructions and precautions for mindfulness, such as “adjusting posture, focusing on breathing, following audio instructions,” and then played the corresponding audio according to the schedule, observing the mother’s reaction, and providing relevant guidance and assistance. After completing mindfulness, the mother listened to light music until the KMC ended.
Routine care
In addition to the different mindfulness interventions used by the two groups of mothers during KMC, their premature infants had the same treatment and feeding strategies during hospitalization. They were performed according to the protocol of the NICU.
Research tools
The mother was required to complete the following three questionnaires on the day before the beginning of mindfulness and the day after it ended. All survey questionnaires were approved and authorized for use in our research.
The changes in mothers’ mindfulness before and after the nurse-assisted mindfulness intervention were measured via the Five Facet Mindfulness Questionnaire (FFMQ) [21], a 39-item questionnaire that measures five facets of mindfulness: (1) observing (8 items); (2) describing (8 items); (3) acting with awareness (8 items); (4) non-judging (8 items); and (5) non-reacting (7 items). The items are scored on a 5-point Likert-type scale ranging from 1 (never or very rarely true) to 5 (very often or always true). The scores were summed, with higher scores indicating greater levels of mindfulness.
The parental stressor scale scores mothers’ stress during hospitalization in the neonatal intensive care unit (PSS: NICU) [22]. It consists of 46 items with four subscales: (1) parental role alteration (11 items); (2) infant appearance/behaviour (19 items); (3) sights and sounds encountered in the NICU (5 items); and (4) parent relationships with staff (11 items). Our study focused on mothers’ stress levels. Thus, the Metric-II scoring procedure was used to provide an overall mean stress score for each subscale ranging from 1 (not at all stressful) to 5 (extremely stressful).
The mother’s general psychological distress and how she had felt in the past week were assessed indicatively by the Hospital Anxiety and Depression Scale (HADS) [23, 24], which comprises two 7-item subscales, anxiety and depression, each scored on a 4-point Likert-type scale and ranging from 0 to 3, with higher scores indicating greater severity. The following cut-offs are recommended: a score of 0–7 for regular or no depression/anxiety, 8–10 for mild, 11–15 for moderate, and ≥ 16 for severe [25].
Mothers were asked to complete a 4-point Likert scale questionnaire developed by our research team to assess the acceptability of the nurse-assisted mindfulness intervention. Our team developed a feasibility assessment form that encompasses resource availability, data collection procedures, proficiency in adopting new technologies, and the replicability of research.
Steering and monitoring of the trial
The Trial Guidance Committee (TGC), consisting of the PI, neonatologists, and psychologists, was established. Regular meetings were held by telephone at least once per quarter during the entire trial period. An independent Data Monitoring Committee (DMC) was established, including one biostatistician and two experts in neonatology. The biostatistician conducted an interim analysis every six months, evaluated the safety and effectiveness of the trial and decided whether to adjust the trial protocol on the basis of the results of the interim study. The Clinical Trials Unit (CTU) of Fujian Provincial Maternal and Child Health Hospital also provided assistance. The guideline for trial discontinuation is incidence of serious adverse events related to the intervention of greater than 20%.
Sample size calculation
This study is a randomized controlled trial (RCT). We estimated the sample size on the basis of the calculation formula of two independent proportions (pooled). The primary outcomes were the the total scores of the questionnaires of PSS: NICU completed by the mothers. According to a literature review [26] and the results of the pre-experiment, a follow-up failure rate of 5% was assumed, and a sample size of 39 participants in each group was calculated via PASS 15.0 (α = 0.05 and β = 0.8).
$$n = \frac{(z_{\alpha} + z_{\beta})^2 \ast 2 \sigma^2}{\delta^2}$$
(1)
Statistical analysis
The data were analysed and processed via SPSS statistical software (SPSS for IBM, Version 23.0.0). Continuous variables with a normal distribution are presented as the means (\(\:\stackrel{-}{\text{x}}\)± s) and were compared via Student’s t test. Continuous variables with nonnormal distributions are presented as medians and interquartile ranges and were compared via the Mann–Whitney test. Dichotomous or nominal categorical variables were compared via the appropriate chi-square test or Fisher’s exact test. We evaluated the trends of maternal questionnaire scores over time by comparing the control group and intervention group at two different time points before and after intervention via a general linear model with repeated measurements for analysis of variance. Studentized residuals are used to judge anomaly values. The normality of the Studentized residuals was detected via the Shapiro‒Wilk test. Spearman correlation tests were used to assess the correlations among mindfulness, stress, anxiety, and depression scores. The test level was set at both sides as α = 0. P < 0.05 was considered statistically significant. Multiple independent hypotheses were simultaneously tested on the same data set via Bonferroni correction.
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