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Effect of Play Therapy with Stress Ball on Pain and Physiological Indicators during Port-A-Cath Needle Insertion in Children Undergoing Chemotherapy

Effect of Play Therapy with Stress Ball on Pain and Physiological Indicators during Port-A-Cath Needle Insertion in Children Undergoing Chemotherapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250318065123N1
Enrollment
80
Registered
2025-05-10
Start date
2025-05-22
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Port-A-Cath Needle Insertion.

Interventions

Intervention 1: Intervention group: The researcher will give each child in the intervention group a stress ball. In this study, Iranian brand multi-colored soft silicone stress balls with a diameter o

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 7 Years

Inclusion criteria

Inclusion criteria: Children aged 3 to 7 years with a port and undergoing chemotherapy Child is conscious and clinically stable Absence of hearing and vision disorders in the child The child's ability to move their hands (to squeeze a stress ball)

Exclusion criteria

Exclusion criteria: Use relaxation and distraction techniques (except for the hospital routine) Use of sedatives and analgesics within 6 hours before the intervention

Design outcomes

Primary

MeasureTime frame
Pain is a score based on the FLACC pain scale and the Wong Baker facial pain rating scale for the study samples. The total score ranges from 0 to 10. An increase in the score at each level indicates an increase in pain intensity. A total score of 0 is interpreted as no pain, 1-2 as mild pain, 3-6 as moderate pain, and 7-10 as severe pain. Timepoint: The FLACC scale and Wong Baker face scale will be completed exactly 10 minutes before port needle insertion in both intervention and control groups as baseline values. After the intervention, FLACC scale will be completed again by the researcher during port needle insertion in both intervention and control groups, and immediately after port needle insertion, each child will be asked to again select one of the colored faces of the Wong Baker scale based on the most pain they felt during port needle insertion, thus the child will rate the severity of their pain. Method of measurement: Pain is a score based on the FLACC pain scale and the Wong Baker facial pain rating scale for the study samples.

Secondary

MeasureTime frame
A secondary outcome could be heart rate (beats / minute). Timepoint: They will be completed exactly 10 minutes before the port needle is inserted in both the intervention and control groups as baseline values. After the intervention, they will be completed again by the researcher during the port needle insertion in both the intervention and control groups. Method of measurement: The heart rate (beats / minute) is measured by a pulse oximeter placed on the child's big toe and displayed by a monitor connected to the child.;The secondary outcome can be systolic and diastolic blood pressure (mmHg). Timepoint: They will be completed exactly 10 minutes before the port needle is inserted in both the intervention and control groups as baseline values. After the intervention, they will be completed again by the researcher during the port needle insertion in both the intervention and control groups. Method of measurement: Systolic and diastolic blood pressure (mmHg) is measured by a blood pressure cuff appropriate for the child's age and size, attached to the right arm, and displayed by a monitor attached to the child.;A secondary outcome could be arterial blood oxygen saturation (percentage). Timepoint: They will be completed exactly 10 minutes before the port needle is inserted in both the intervention and control groups as baseline values. After the intervention, they will be completed again by the researcher during the port needle insertion in both the intervention and control groups. Method of measurement: Arterial blood oxygen saturation (percentage) is measured by a pulse oximeter placed on the child's big toe and displayed by a monitor attached to the child.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFahimeh Sabeti

Iran University of Medical Sciences

sabeti.f@iums.ac.ir+98 21 8888 2886

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 26, 2026