The Effect of Therapeutic Play on Pain, Fear, Anxiety and Physiological Parameters and Parents' Satisfaction

NCT06415188 | Completed

• 1 other identifier: SelcukUni2544
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the effect of the therapeutic game applied before treatment on pain, fear, anxiety and physiological parameters and the satisfaction of the parents was investigated.

Conditions

Child Behavior; Pain, Acute; Anxiety and Fear

Keywords

Pain; anxiety; children; nursing; therapeutic play

Outcome Measures

Primary Outcomes (5)

• Descriptive Characteristics Information Form

  A descriptive characteristics information form for parents and children was prepared by the researchers in line with the literature and the data of both the experimental and control groups were collected before the intervention.

  First measurement: 30 minute before treatment

• Physiological Parameter Monitoring Form

  The descriptive characteristics form was based on a literature review by the investigator. Heart rate (min), oxygen saturation (SpO2%), blood pressure (mmHg) and respiratory rate (min) were measured 1 minute before treatment administration.

  First measurement: 1 minute before treatment

• Children's State Anxiety and Children's Fear Scale

  Children's State Anxiety and Children's Fear Scale was developed by McMurtry et al. in 2011. The scale was designed to measure the fear levels of children aged 4-10 years. The scale was translated into Turkish by Gerçeker et al. in 2018 and the validity-reliability coefficient was found to be 0.89. The scale score is formed by scoring five drawn facial expressions (0=no fear to 4=severe fear) shown visually to the child. Anxiety and fear scores of the child were scored one minute before the treatment.

  First measurement: 1 minute before treatment

• Visual Analog Scale

  Visual Analog Scale (VAS) was developed by Wong and Baker in 1988. Patients' pain levels are evaluated by scoring with facial expressions. It is used in children who have the ability to communicate and are conscious. The scale has 6 faces that are scored between 0 and 5. In scoring, the child chooses the face that best expresses him/her and "0" indicates no pain, "1" indicates a little pain, "2" indicates a little more pain, "3" indicates more pain, "4" indicates quite a lot of pain and "5" indicates the most severe pain level. One minute before the treatment, the child's pain is scored by VAS.

  First measurement: 1 minute before treatment

• PedsQL Health Care Satisfaction Scale

  The PedsQL Health Care Satisfaction Scale was developed by J.W. Varni in 1999. Turkish adaptation of the scale was conducted by Ulus and Kublay in 2012. The scale consists of 25 items with 6 subheadings: emotional support, information, general satisfaction, communication, family involvement and technical skills. The scale is on a five-point scale and each item is rated on a scale of 0 to 4 and is evaluated as "Never satisfied (0)", "Sometimes satisfied (1)", "Most of the time satisfied (2)", "Almost always satisfied (3)" and "Always satisfied (4)". A high score indicates an increase in parental satisfaction.

  First measurement: After treatment

Secondary Outcomes (3)

• Physiological Parameter Monitoring Form

  Second measurement: 1 minute after treatment

• Children's State Anxiety and Children's Fear Scale

  Second measurement: 1 minute after treatment

• Visual Analog Scale

  Second measurement: 1 minute after treatment

Study Arms (2)

Therapeutic play group

EXPERIMENTAL

Children in the experimental group received a therapeutic video game intervention in addition to the pre-treatment routine.

Behavioral: Video game with headset

Control Group

NO INTERVENTION

Children in the control group underwent routine clinical practice. No other intervention was performed.

Interventions

Video game with headset BEHAVIORAL

Half an hour before the first treatment in the morning, the screens around the patients' beds were closed by the researcher. The child was asked to choose one of the introduced games and the game he/she chose from the tablet was turned on. Children were asked to wear headphones for sound isolation and the sound was adjusted at the appropriate decibel setting. Half an hour before the treatment, children were allowed to play the video game until the treatment without any different warning. Physiologic Parameter Assessment Form, Child Anxiety and Fear Scale, Child Pain Scale were filled by the researcher 1 minute before and 1 minute after the procedure. Finally, Parental Satisfaction Scale was completed at the end of the intervention.

Therapeutic play group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Being in the 3-6 age group,
• At least one day of inpatient treatment in the pediatric clinics of Selçuk Medical Faculty Hospital
• At least one invasive intervention in the treatment plan
• To be able to understand and speak Turkish
• Staying in a room with at least two beds

You may not qualify if:

• Having a neurological disorder
• Not having a parent as a companion
• Receiving oral treatment only
• Hearing and vision problems
• Single bed capacity room or isolated room
• For the Parent
• Staying with their child as a constant companion
• To be able to understand and speak Turkish
• Accepting to participate in the study
• Not staying with your child all the time

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University

Konya, Turkey (Türkiye)

Location

Related Publications (7)

• Bergomi P, Scudeller L, Pintaldi S, Dal Molin A. Efficacy of Non-pharmacological Methods of Pain Management in Children Undergoing Venipuncture in a Pediatric Outpatient Clinic: A Randomized Controlled Trial of Audiovisual Distraction and External Cold and Vibration. J Pediatr Nurs. 2018 Sep-Oct;42:e66-e72. doi: 10.1016/j.pedn.2018.04.011. Epub 2018 May 1.

  PMID: 29728296 BACKGROUND

• Silva SGTD, Santos MA, Floriano CMF, Damiao EBC, Campos FV, Rossato LM. Influence of Therapeutic Play on the anxiety of hospitalized school-age children: Clinical trial. Rev Bras Enferm. 2017 Nov-Dec;70(6):1244-1249. doi: 10.1590/0034-7167-2016-0353. English, Portuguese.

  PMID: 29160486 BACKGROUND

• Roberts JG, Prys-Roberts C, Foex P, Clarke TN, Bennett M. Proceedings: A comparison of the effects of practolol and propranolol on the response to haemorrhage in anaesthetized dogs after myocardial infarction. Br J Anaesth. 1973 Dec;45(12):1230. doi: 10.1093/bja/45.12.1230. No abstract available.

  PMID: 4787017 BACKGROUND

• Kose S, Arikan D. The Effects of Cartoon Assisted Endoscopy Preparation Package on Children's Fear and Anxiety Levels and Parental Satisfaction in Turkey. J Pediatr Nurs. 2020 Jul-Aug;53:e72-e79. doi: 10.1016/j.pedn.2020.02.010. Epub 2020 Mar 13.

  PMID: 32173165 BACKGROUND

• Inan G, Inal S. The Impact of 3 Different Distraction Techniques on the Pain and Anxiety Levels of Children During Venipuncture: A Clinical Trial. Clin J Pain. 2019 Feb;35(2):140-147. doi: 10.1097/AJP.0000000000000666.

  PMID: 30362982 BACKGROUND

• Masmoudi A, el-Fetouaki J, Weltin D, Belhadj O, Mandel P. Association of mitochondrial ADP-ribosyl transferase activity with the DNA-protein complex. Biochem Mol Biol Int. 1993 Jan;29(1):77-83.

  PMID: 8387848 BACKGROUND

• Burns-Nader S, Joe L, Pinion K. Computer tablet distraction reduces pain and anxiety in pediatric burn patients undergoing hydrotherapy: A randomized trial. Burns. 2017 Sep;43(6):1203-1211. doi: 10.1016/j.burns.2017.02.015. Epub 2017 Mar 18.

  PMID: 28318748 BACKGROUND

MeSH Terms

Conditions

Child Behavior; Acute Pain; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Sibel Kucukoglu, Prof

  Selcuk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: This study was conducted on children aged 3-6 years. The study was completed with a total of 40 children and parent pairs in the experimental and control groups. Simple randomization method was used in the study. The randomization table for which group the children would be in was made by an independent statistician. Letters A and B were used to represent the experimental and control groups. Which letter represented which group was determined by lottery. While therapeutic play intervention was applied in the experimental group, routine intervention was applied in the control group.

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: May 15, 2023
• Primary Completion: April 15, 2024
• Study Completion: May 10, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)