The present randomized clinical trial was conducted on 80 mothers, whose premature infants were hospitalized in the NICU of two hospitals in northern Iran in 2018. The study was registered in the Iranian Registry of Clinical Trials (IRCT) (registration number: IRCT20171205037765N1). The sampling method used in the first stage was convenience sampling, which was then shifted to random sampling by assigning even and odd numbers to the questionnaires of each of the intervention and control groups. The participants were divided into two equal groups (n = 40) of experimental and control. All participants were given a Profile of Mood States (POMS) questionnaire both at the time of admission and discharge. The experimental group received positive touch from the beginning of admission to the NICU until the time of discharge, while the control group only received the routine care. The inclusion criteria were mothers over 18 years of age, able to read and write, with no chronic mental or physical illnesses, and having an infant with no chromosomal abnormality. The exclusion criteria were a length of stay shorter than 10 days and longer than two months for the infant and the mother’s unwillingness to participate in the study. The required sample size was calculated to be 40 for each of the study groups, assuming a confidence level of 95% and power of 80%. Any mother who entered the NICU and met the inclusion criteria was informed about the research objectives and the way the study was conducted. Those who were willing to participate were asked to give an informed consent and were given a questionnaire. Then, they were consecutively assigned to one of the two study groups by computer randomization. In the experimental group, the intervention (positive touch) was performed at any time of the day, when the mother had the ability to enter the unit and visit her infant. The control group received the usual care and support. The researcher initially gave the experimental group the required training on how to perform the positive touch, i.e., touching, holding, massaging, and kangaroo care, using a soft doll. The mothers were also provided with the training contents in the form of an educational brochure. It should be noted that positive touch care is not routinely performed in the neonatal wards.
The positive touch includes the following stages:
- Preparation and observation: Providing an opportunity for the mother to express her feelings and fear, free her mind to concentrate, and see the infant.
- Mother’s presence without touching: Sitting quietly at infant’s bedside, reaching out the hand and holding it a few centimeters away from the infant’s head or feet, taking a slow, deep breath to reduce tension, and envisioning the comforting glow that can encircle the infant to help the mother relax.
- Initiating touch (permission): Conveying the intention of the forthcoming contact, deciding about infant’s readiness based on medical condition and behavioral state, waiting for signals of acceptance, preparing the environment by reducing the lighting and the noise level, and ensuring warmth and convenience by the nurse.
- Still holding/containment: Gently stroking with the fingertips, cupping the hands around the infant’s head, feet or hands, leading the infant into a quiet and relaxed state.
- Pacing: Adjusting the intensity, speed, and duration of the touch/massage to avoid overreaction of hypersensitive infants to help the infants respond and to provoke self-regulation.
- Kangaroo care: cuddling, caressing, and affectionately touching the infant, considering the NICU’s procedures, the infant’s individual needs, the daily rhythms of sleep, and the mother’s tendency to skin-to-skin touch.
- Letting go: Initiating the departure of the touch slowly, conveying the intention of forthcoming departure verbally or with silent intent, the hand rests still before the mother leaves, she gradually slows down the movement of her hand and then holds it still (
16).
In implementing the positive touch, it is better to avoid predetermined time and duration and initiate the movement regularly and in a predictable way every day if circumstances allow. We begin with one slow but firm movement at a time on a part of body, where the infant appears to like (usually the head, hands or feet) and continue with a pressure deeper than a tickle stimulus, until it increases the production of behavior in response to the massage movements, which are rhythmical. If the infant trusts and tolerates the massaging, we gradually increase the number of sessions to more than one session per day up to a maximum of three times a day. The experimental group received the positive touch from the beginning of the infant’s admission to the NICU until the time of discharge.
The data collection instrument in the present study was the POMS questionnaire, which included two parts: (1) demographic characteristics (the mother’s age, level of education, and the infant’s birth order; the infant’s weight); (2) questions regarding the mood state. The POMS questionnaire contains 65 questions, measuring six different dimensions of the mood swings including tension-anxiety, anger-hostility, vigor, fatigue, depression, and confusion. We used a five-point Likert scale ranging from 0 (not at all) to 4 (extremely) to assign the scores. The range of scores for each subscale was as follows: (1) 0 - 36 for anxiety; (2) 0 - 60 for depression; (3) 0 - 48 for anger; (4) 0 - 32 for vigor; (5) 0 - 28 for fatigue; and (6) 0 - 28 for confusion. In order to calculate the total mood disturbance (TMD), we added the total scores for the five negative subscales, including anxiety, depression, anger, fatigue, and confusion and then subtracted the score for the positive subscale, which is vigor. Therefore, the TMD ranged from 0 to 168 and the lower score indicated a better mood (
17). The number of items dedicated to each subscale of the mood state was nine for anxiety, 15 for depression, 12 for anger, eight for vigor, seven for fatigue, and seven for confusion. It took 3 - 7 minutes for healthy participants to complete the questionnaire and for those who were physically ill, it took longer. All the mothers in the experimental group completed the questionnaire once at the beginning of the study and once at the time of the infant’s discharge from the NICU. The mothers in the control group, who received no intervention and contacted their infants according to the routine procedures of the ward, completed the questionnaire twice like the mothers in the experimental group. The primary outcome of this study was the effect of positive touch on maternal mood states and its secondary outcome was the effect of positive touch on mother-infant interactions. The sampling process lasted for six months (
Figure 1).
The flow diagram of study design
In a study, Shafiei et al. used the content validity method to determine the validity of the POMS questionnaire. According to their findings, Cronbach’s alpha was 0.95 and Pearson correlation coefficient was 0.97 for anxiety, 0.95 for vigor, 0.98 for fatigue, and 0.98 for confusion (
17). In the present study, Cronbach’s alpha for each subscale was as follows: (1) 0.733 for tension, (2) 0.924 for depression, (3) 0.868 for anger, (4) 0.855 for fatigue, (5) 0.733 for vigor, (6) 0.703 for confusion, and (7) 0.934 for the TMD. The obtained data was coded and analyzed using SPSS software version 22. Data analysis was performed using chi-square, paired t-test, and independent
t-test. A P-value of less than 0.05 was considered significant.