Effectiveness of skin-to-skin contact versus care-as-usual in mothers and their full-term infants: study protocol for a parallel-group randomized controlled trial

Kelly H M Cooijmans, Roseriet Beijers, Anne C Rovers, Carolina de Weerth, Kelly H M Cooijmans, Roseriet Beijers, Anne C Rovers, Carolina de Weerth

Abstract

Background: Twenty-to-forty percent of women experience postpartum depressive symptoms, which can affect both the mother and infant. In preterm infants, daily skin-to-skin contact (SSC) between the mother and her infant has been shown to decrease maternal postpartum depressive symptoms. In full-term infants, only two studies investigated SSC effects on maternal depressive symptoms and found similar results. Research in preterm infants also showed that SSC improves other mental and physical health outcomes of the mother and the infant, and improves the quality of mother-infant relationship. This randomized controlled trial will investigate the effects of a SSC intervention on maternal postpartum depressive symptoms and additional outcomes in mothers and their full-term infants. Moreover, two potential underlying mechanisms for the relation between SSC and the maternal and infant outcomes will be examined, namely maternal oxytocin concentrations and infant intestinal microbiota.

Methods/design: Design: A parallel-group randomized controlled trial.

Participants: 116 mothers and their full-term infants.

Intervention: Mothers in the SSC condition will be requested to provide daily at least one continuous hour of SSC to their infant. The intervention starts immediately after birth and lasts for 5 weeks. Mothers in the control condition will not be requested to provide SSC. Maternal and infant outcomes will be measured at 2 weeks, 5 weeks, 12 weeks and 1 year after birth.

Primary outcome: maternal postpartum depressive symptoms. Secondary maternal outcomes: mental health (anxiety, stress, traumatic stress following child birth, sleep quality), physical health (physical recovery from the delivery, health, breastfeeding, physiological stress), mother-infant relationship (mother-infant bond, quality of maternal caregiving behavior). Secondary infant outcomes: behavior (fussing and crying, sleep quality), physical health (growth and health, physiological stress), general development (regulation capacities, social-emotional capacities, language, cognitive and motor capacities). Secondary underlying mechanisms: maternal oxytocin concentrations, infant intestinal microbiota.

Discussion: As a simple and cost-effective intervention, SSC may benefit both the mother and her full-term infant in the short-and long-term. Additionally, if SSC is shown to be effective in low-risk mother-infant dyads, then thought could be given to developing programs in high-risk samples and using SSC in a preventive manner.

Trial registration: NTR5697 ; Registered on March 13, 2016.

Keywords: Full-term infants; Infant behavior; Mental health; Mother-infant relationship; Physical health; Postpartum depressive symptoms; Randomized controlled trial; Skin-to-skin contact.

Conflict of interest statement

Ethics approval and consent to participate

The trial has been approved by the ethics committee of the Social Science faculty of the Radboud University, The Netherlands (ECSW2015–2311-358). Written consent will be obtained from participants.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Participant flow
Fig. 2
Fig. 2
Study procedure

References

    1. McCoy SJB, Beal JM, Shipman SM, Payton ME, Watson GH. Risk factors for postpartum depression: a retrospective investigation at 4-weeks postnatal and a review of the literature. J Am Osteopath Assoc. 2006;106:193–198.
    1. Morris-Rush JK, Freda MC, Bernstein PS. Screening for postpartum depression in an inner city population. Am J Obstet Gynecol. 2003; doi:10.1067/mob.2003.279.
    1. Yelland J, Sutherland G, Brown SJ. Postpartum anxiety, depression and social health: findings from a population-based survey of Australian women. BMC Public Health. 2010; doi:10.1186/1471-2458-10-771.
    1. Field T. Postpartum depression effects on early interactions, parenting, and safety practices: a review. Infant Behav Dev. 2010; doi:10.1016/j.infbeh.2009.10.005.
    1. Conroy S, Pariante CM, Marks MN, Davies HA, Farrelly S, Schacht R, Moran P. Maternal psychopathology and infant development at 18 months: the impact of maternal personality disorder and depression. J Am Acad Child Adolesc Psychiatry. 2012; doi:10.1016/j.jaac.2011.10.007.
    1. Grace SL, Evindar A, Stewart DE. The effect of postpartum depression on child cognitive development and behavior: a review and critical analysis of the literature. Arch Womens Ment Health. 2003;6:263–274. doi: 10.1007/s00737-003-0024-6.
    1. Josefsson A, Sydsjö G. A follow-up study of postpartum depressed women: recurrent maternal depressive symptoms and child behavior after four years. Arch Womens Ment Health. 2007;10:141–145. doi: 10.1007/s00737-007-0185-9.
    1. Dennis CL, Hodnett E. Psychosocial and psychological interventions for treating postpartum depression. Cochrane Database Syst Rev. 2007; doi:10.1002/14651858.CD006116.
    1. Seehusen DA, Baldwin LM, Runkle GP, Clark G. Are family physicians appropriately screening for postpartum depression? J Am Board Fam Pract. 2005; doi:10.3122/jabfm.18.2.104.
    1. Ballestrem CLV, Strauss M, Kächele H. Contribution to the epidemiology of postnatal depression in Germany–implications for the utilization of treatment. Arch Womens Ment Health. 2005;8:29–35. doi: 10.1007/s00737-005-0068-x.
    1. Department of Reproductive Health and Research. Kangaroo mother care - a practical guide. In: Maternal, newborn, child and adolescent health. World Health Organization. 2003. . Accessed 22 June 2016.
    1. De Alencar AEMA, Arraes LC, De Albuquerque EC, Alves JGB. Effect of kangaroo mother care on postpartum depression. J Trop Pediatr. 2009; doi:10.1093/tropej/fmn083.
    1. Feldman R, Eidelman AI, Sirota L, Weller A. Comparison of skin-to-skin (kangaroo) and traditional care: parenting outcomes and preterm infant development. Pediatrics. 2002; doi:10.1542/peds.110.1.16.
    1. Dombrowski MA, Anderson GC, Santori C, Burkhammer M. Kangaroo (skin-to-skin) care with a postpartum woman who felt depressed. MCN Am J Matern Child Nurs. 2001; doi:10.1097/00005721-200107000-00012.
    1. Bigelow A, Power M, MacLellan-Peters J, Alex M, McDonald C. Effect of mother/infant skin-to-skin contact on postpartum depressive symptoms and maternal physiological stress. J Obstet Gynecol Neonatal Nurs. 2012; doi:10.1111/j.1552-6909.2012.01350.
    1. Feldman R, Rosenthal Z, Eidelman AI. Maternal-preterm skin-to-skin contact enhances child physiologic organization and cognitive control across the first 10 years of life. Biol Psychiatry. 2014; doi:10.1016/j.biopsych.2013.08.012.
    1. Feldman R, Weller A, Sirota L, Eidelman AI. Testing a family intervention hypothesis: the contribution of mother-infant skin-to-skin contact (kangaroo care) to family interaction, proximity, and touch. J Fam Psychol. 2003; doi:10.1037/0893-3200.17.1.94.
    1. Flacking R, Ewald U, Wallin L. Positive effect of kangaroo mother care on long-term breastfeeding in very preterm infants. J Obstet Gynecol Neonatal Nurs. 2011; doi:10.1111/j.1552-6909.2011.01226.x.
    1. Moore ER, Anderson GC, Bergman N, Dowswell T. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2012; doi:10.1002/14651858.CD003519.pub3.
    1. Walters MW, Boggs KM, Ludington-Hoe S, Price KM, Morrison B. Kangaroo care at birth for full term infants: a pilot study. MCN Am J Matern Child Nurs. 2007; doi:10.1097/01.NMC.0000298134.39785.6c.
    1. Charmandari E, Tsigos C, Chrousos G. Endocrinology of the stress response 1. Annu Rev Physiol. 2005; doi:10.1146/annurev.physiol.67.040403.120816.
    1. De Niet G, Tiemens B, Lendemeijer B, Hutschemaekers G. Music-assisted relaxation to improve sleep quality: meta-analysis. J Adv Nurs. 2009; doi:10.1111/j.1365-2648.2009.04982.x.
    1. Grossman P, Niemann L, Schmidt S, Walach H. Mindfulness-based stress reduction and health benefits: a meta-analysis. J Psychosom Res. 2004; doi:10.1016/S0022-3999(03)00573-7.
    1. Broadbent E, Kahokehr A, Booth RJ, Thomas J, Windsor JA, Buchanan CM, et al. A brief relaxation intervention reduces stress and improves surgical wound healing response: a randomised trial. Brain Behav Immun. 2012; doi:10.1016/j.bbi.2011.06.014.
    1. Stadler G, Snyder KA, Horn AB, Shrout PE, Bolger NP. Close relationships and health in daily life: a review and empirical data on intimacy and somatic symptoms. Psychosom Med. 2012; doi:10.1097/PSY.0b013e31825473b8.
    1. Field T. Touch for socioemotional and physical well-being: a review. Dev Rev. 2010; doi:10.1016/j.dr.2011.01.001.
    1. Ludington-Hoe SM, Morgan K, Abouelfelttoh A. A clinical guideline for implementation of kangaroo care with premature infants of 30 or more weeks postmenstrual age. Adv Neonatal Care. 2008; doi:10.1097/01.anc.0000324330.25734.b6.
    1. Mörelius E, Örtenstrand A, Theodorsson E, Frostell A. A randomised trial of continuous skin to skin contact after preterm birth and the effects on salivary cortisol, parental stress, depression, and breastfeeding. Early Hum Dev. 2015; doi:10.1016/j.eearlyhumdev.2014.12.005.
    1. Okan F, Ozdil A, Bulbul A, Yapici Z, Nuhoglu A. Analgesic effects of skin-to-skin contact and breastfeeding in procedural pain in healthy term neonates. Ann Trop Paediatr. 2010; doi:10.1179/146532810X1270390251612.
    1. Beijers R, Cillessen L, Zijlmans MAC. An experimental study on mother-infant skin-to-skin contact in full-terms. Infant Behav Dev. 2016; doi:10.1016/j.infbeh.2016.01.00.
    1. Morgan BE, Horn AR, Bergman NJ. Should neonates sleep alone? Biol Psychiatry. 2011; doi:10.1016/j.biopsych.2011.06.018.
    1. Uvnäs-Moberg K, Handlin L, Petersson M. Self-soothing behaviors with particular reference to oxytocin release induced by non-noxious sensory stimulation. Front Psychol. 2015; doi:10.3389/fpsyg.2014.01529.
    1. Jonas K, Johansson LM, Nissen E, Ejdeback M, Ransjo-Arvidson AB, Uvnäs-Moberg K. Effects of intrapartum oxytocin administration and epidural analgesia on the concentration of plasma oxytocin and prolactin, in response to suckling during the second day postpartum. Breastfeed Med. 2009; doi:10.1089/bfm.2008.0002.
    1. Feldman R, Gordon I, Schneiderman I, Weisman O, Zagoory-Sharon O. Natural variations in maternal and paternal care are associated with systematic changes in oxytocin following parent–infant contact. Psychoneuroendocrinology. 2010; doi:10.1016/j.psyneuen.2010.01.013.
    1. Galbally M, Lewis AJ, IJzendoorn MV, Permezel M. The role of oxytocin in mother-infant relations: a systematic review of human studies. Harv Rev Psychiatry. 2011; doi:10.3109/10673229.2011.549771.
    1. Tannock GW, Fuller R, Smith SL, Hall MA. Plasmid profiling of members of the family enterobacteriaceae, lactobacilli, and bifidobacteria to study the transmission of bacteria from mother to infant. J Clin Microbiol. 1990;28:1225–1228.
    1. Palmer C, Bik EM, DiGiulio DB, Relman DA, Brown PO. Development of the human infant intestinal microbiota. PLoS Biol. 2007; doi:10.1371/journal.pbio.0050177.
    1. Dimmitt RA, Staley EM, Chuang G, Tanner SC, Soltau TD, Lorenz RG. The role of postnatal acquisition of the intestinal microbiome in the early development of immune function. J Pediatr Gastroenterol Nutr. 2010; doi:10.1097/MPG.0b013e3181e1a114.
    1. Sekirov I, Russell SL, Antunes CM, Finlay B. Gut microbiota in health and disease. Physiol Rev. 2010; doi:10.1152/physrev.00045.2009.
    1. De Weerth C, Fuentes S, Puylaert P, De Vos WM. Intestinal microbiota of infants with colic: development and specific signatures. Pediatrics. 2013; doi:10.1542/peds.2012-1449.
    1. Bäckhed F, Roswall J, Peng Y, Feng Q, Jia H, Kovatcheva-Patchary P, et al. Dynamics and stabilization of the human gut microbiome during the first year of life. Cell Host Microbe. 2015; doi:10.1016/j.chom.2015.04.004.
    1. Petherick A. Mother's milk: a rich opportunity. Nature. 2010; doi:10.1038/468S5a.
    1. Dinan TG, Cryan JF. Regulation of the stress response by the gut microbiota: implications for psychoneuroendocrinology. Psychoneuroendocrinology. 2012; doi:10.1016/j.psyneuen.2012.03.007.
    1. Galley JD, Nelson MC, Yu Z, Dowd SE, Walter J, Kumar PS, et al. Exposure to a social stressor disrupts the community structure of the colonic mucosa-associated microbiota. BMC Microbiol. 2014; doi:10.1186/1471-2180-14-189.
    1. Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013; doi:10.7326/0003-4819-158-3-201302050-00583.
    1. Faul F, Erdfelder E, Lang AG, Buchner A. G* power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007; doi:10.3758/BF03193146.
    1. Beijers R, Riksen-Walraven JM, de Weerth C. Cortisol regulation in 12-month-old human infants: associations with the infants’ early history of breastfeeding and co-sleeping. Stress. 2013; doi:10.3109/10253890.2012.742057.
    1. National Statistics Database. Statistics Netherlands, The Hague. 2014. . Accessed 22 June 2016.
    1. Suresh KP. An overview of randomization techniques: an unbiased assessment of outcome in clinical research. J Hum Reprod Sci. 2011; doi:10.4103/0974-1208.82352.
    1. Stern E, Parmelee AH, Akiyama Y, Schultz MA, Wenner WH. Sleep cycle characteristics in infants. Pediatrics. 1969;43:65–70.
    1. Jansen J, Beijers R, Riksen-Walraven M, de Weerth C. Cortisol reactivity in young infants. Psychoneuroendocrinology. 2010; doi:10.1016/j.psyneuen.2009.07.008.
    1. Rubin DB. Multiple imputation for nonresponse in surveys. Classic. New York: Wiley; 2004.
    1. Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh postnatal depression scale. Brit J Psychiat. 1987; doi:10.1192/bjp.150.6.782.
    1. Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the State-trait anxiety inventory. Revised. Palo Alto: Consulting Psychologists Press; 1983.
    1. Vingerhoets AJJM, Jeninga AJ, Menges LJ. The measurement of daily hassles and chronic stressors: the development of the everyday problem checklist (EPCL, Dutch-APL). Gedrag Gezond 1989;17:10-7.
    1. Wijma K, Soderquist J, Wijma B. Posttraumatic stress disorder after childbirth: a cross sectional study. J Anxiety Disord. 1997; doi:10.1016/S0887-6185(97)00041-8.
    1. Akerstedt T, Hume KEN, Minors D, Waterhouse JIM. The subjective meaning of good sleep, an intraindividual approach using the Karolinska sleep diary. Percept Mot Skills. 1994; doi:10.2466/pms.1994.79.1.287.
    1. Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989; doi:10.1016/0165-1781(89)90047-4.
    1. Smets EMA, Garssen B, Bonke BD, De Haes JCJM. The Multidimensional fatigue inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995; doi:10.1016/0022-3999(94)00125-O.
    1. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Med Care. 1992; doi:10.1097/00005650-199206000-00002.
    1. Beijers R, Jansen J, Riksen-Walraven M, de Weerth C. Maternal prenatal anxiety and stress predict infant illnesses and health complaints. Pediatrics. 2010; doi:10.1542/peds.2009-3226.
    1. Condon JT, Corkindale CJ. The assessment of parent-to-infant attachment: development of a self-report questionnaire instrument. J Reprod Infant Psyc. 1998; doi:10.1080/02646839808404558.
    1. Ainsworth MD, Blehar MC, Waters E, Wall S. Patterns of attachment: a psychological study of the strange situation. 1. Hillsdale: Lawrence Erlbaum Associates; 1978.
    1. Tollenaar MS, Beijers R, Jansen J, Riksen-Walraven JMA, De Weerth C. Solitary sleeping in young infants is associated with heightened cortisol reactivity to a bathing session but not to a vaccination. Psychoneuroendocrinology. 2012; doi:10.1016/j.psyneuen.2011.03.017.
    1. De Weerth C, Jansen J, Vos MH, Maitimu I, Lentjes EG. A new device for collecting saliva for cortisol determination. Psychoneuroendocrinology. 2007; doi:10.1016/j.psyneuen.2007.07.005.
    1. Barr RG, Kramer MS, Boisjoly C, McVey-White L, Pless IB. Parental diary of infant cry and fuss behavior. Arch Dis Child. 1988; doi:10.1136/adc.63.4.380.
    1. Sadeh A. A brief screening questionnaire for infant sleep problems: validation and findings for an internet sample. Pediatrics. 2004; doi:10.1542/peds.113.6.e570.
    1. Putnam SP, Helbig AL, Gartstein MA, Rothbart MK, Leerkes E. Development and assessment of short and very short forms of the infant behavior questionnaire–revised. J Pers Assess. 2014; doi:10.1080/00223891.2013.841171.
    1. Squires J, Bricker D. Ages & stages questionnaires, third edition (ASQ-3): a parent-completed child-monitoring system. 3. Baltimore: Brookes Publishing; 2009.
    1. Briggs-Gowan MJ, Carter AS. Brief infant-toddler social and emotional assessment (BITSEA) manual, version 2.0. 2. New Haven: Yale University Press; 2002.
    1. Van den Bergh BR. The influence of maternal emotions during pregnancy on fetal and neonatal behavior. J Prenat Perinat Psychol Health. 1990;5:119–130.
    1. DiPietro JA, Ghera MM, Costigan K, Hawkins M. Measuring the ups and downs of pregnancy stress. J Psychosom Obstet Gynaecol. 2004; doi:10.1080/01674820400017830.
    1. Condon JT. The assessment of antenatal emotional attachment: development of a questionnaire instrument. Brit J Med Psychol. 1993; doi:10.1111/j.2044-8341.1993.tb01739.x.
    1. Anders TF, Keener MA. Developmental course of nighttime sleep-wake patterns in full-term and premature infants during the first year of life, I. Sleep. 1985;8:173–192. doi: 10.1093/sleep/8.3.173.
    1. Keller H, Lamm B, Abels M, Yovsi R, Borke J, Jensen H, et al. Cultural models, socialization goals, and parenting ethnotheories: a multicultural analysis. J Cross-Cult Psychol. 2003; doi:10.1177/0022022105284494.
    1. Rini C, Dunkel Schetter C. The effectiveness of social support attempts in intimate relationships: “T ain’t what you do, it’s the way that you do it.”. In: Sullivan K, Davila J, editors. Support processes in intimate relationships. New York: Oxford University Press; 2010. pp. 26–70.
    1. Wilhelm FH, Kochar AS, Roth WT, Gross JJ. Social anxiety and response to touch: incongruence between self-evaluative and physiological reactions. Biol Psychol. 2001; doi:10.1016/S0301-0511(01)00113-2.
    1. Brennan KA, Clark CL, Shaver PR. Self-report measurement of adult attachment: an integrative overview. In: Simpson JA, Rholes S, editors. Attachment theory and close relationships. New York: Guilford Press; 1998. pp. 46–47.

Source: PubMed

3
Prenumerera