A RANDOMIZED CONTROL TRAIL ON EFFECTIVENESS OF OCTOPUS THERAPY IN ALLEVIATION OF PAIN DURING BASIC NEONATAL PROCEDURES

Abstract

Background and Objectives: Neonates experience pain during medical procedures, which can lead to physiological instability and long-term adverse effects. Crocheted octopus therapy, inspired by neonatal care practices in Denmark, is believed to provide comfort and stabilize vital parameters, but scientific validation remains limited. This study evaluates the effectiveness of octopus therapy in alleviating pain and maintaining physiological stability in neonates undergoing heel lance procedures.
Methods: A randomized controlled trial was conducted with 100 neonates assigned to two groups via www.randomizer.org: Group A (Octopus Therapy, n=50) and Group B (Control, n=50). Inclusion criteria comprised well babies undergoing routine TSH sampling, with parental consent. Exclusion criteria included sick neonates requiring NICU admission,
referred newborns, and those who had undergone prior sampling. Group A received a crocheted octopus toy to grasp 10 minutes before the procedure, while Group B underwent the procedure without any intervention. Pain was assessed using the Neonatal Pain Agitation and Sedation Scale (N-PASS), and physiological parameters (heart rate and oxygen saturation) were monitored at baseline, during the procedure, and at 2 and 10 minutes post-procedure. Data were analyzed using ANOVA and Pearson’s correlation coefficient, with a significance threshold of p<0.05.Results: Baseline characteristics were comparable between groups
(p>0.05). Pain scores were significantly lower in Group A compared to
Group B during (3.8±1.1 vs. 6.5±1.3, p<0.001) and after the procedure (2 min: 2.1±0.8 vs. 4.3±1.2, p<0.001; 10 min: 1.0±0.5 vs. 2.8±1.1, p<0.001). Heart rate was lower in Group A during (150±10 bpm vs. 165±12 bpm,p<0.001) and post-procedure (p<0.001). Oxygen saturation was better maintained in Group A during (94.0±1.8% vs. 91.5±2.2%, p<0.001) and post-procedure (p<0.001). Mean cry duration was significantly shorter in Group A (30.5±10.2 sec vs. 55.8±12.5 sec, p<0.001). Conclusion: Octopus therapy significantly reduces pain scores, stabilizes physiological parameters, and decreases crying duration in neonates undergoing minor procedures. It is a promising adjunct to neonatal pain management strategies. Further multicenter studies are recommended to validate these findings and explore comparisons with established nonpharmacological interventions.