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Completed

NCT Number: NCT06404879

The Effect of Parental Anxiety Level on the Child's Anxiety Level and Postoperative Pain in Children Undergoing Surgery.

The aim of this prospective study is to investigate whether the anxiety levels of parents of children aged 2-6 years who will undergo inguinal area surgery have an effect on the child's preoperative anxiety level and postoperative pain level.

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Key information

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Giresun Gynecology and Pediatrics Training Research Hospital

Giresun, Centre, 28000, Turkey (Türkiye)

About this study

Hospitalization of children for any health problem or treatment is a complex and difficult process that negatively affects the child and his family and creates stress. Surgical treatment in children can be planned or unplanned, minor or major, invasive or non-invasive, but every type of surgery is considered a stressful experience. Studies have shown that by controlling the anxiety and fear experienced in the preoperative period, children can achieve faster recovery in the postoperative period, better pain tolerance and earlier discharge. For this reason, we aim to contribute to the literature by investigating whether the anxiety levels of the parents of children aged 2-6 who will undergo inguinal area surgery affect the child's preoperative anxiety level and postoperative pain level.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The child is between the ages of 2-6
  • Patients scheduled for surgery under general anesthesia due to inguinal area pathology
  • Surgery performed as planned
  • There is no mental or neurological disorder in both the mother and the child.
  • There are no vision, hearing or speech problems in both the mother and the child.
  • Parents and children who volunteer to participate in the research
  • Children with ASA I

Exclusion criteria

  • Not volunteering to participate in the study (those for whom parental consent cannot be obtained)
  • Those who underwent surgery with a pathology other than the inguinal area
  • Having emergency surgery
  • Children at risk with ASA 2 and above
  • Having a pathology that may cause difficulty in communicating with both the family and the child (such as mental retardation, neurological problem).

Treatment and study plan

determining scores with tests

Other

Parents of children preparing for the operation will be given a child and family information form and STAI-I and STAI-II (State-Trait Anxiety Scale) scale forms and will be asked to fill them out themselves.

An anesthesia technician blind to the content of the study will calculate and take notes on the children's anxiety levels, according to the m-YPAS (modified Yale Preoperative Anxiety) scale, in the preoperative waiting room (T1) and when the anesthesia ventilation mask is shown (T4).

FLACC (Face, Legs, Activity, Cry, Consolabilityscale) scores and spO2, pulse values and complications such as nausea, vomiting and desaturation at the 5th, 10th, 20th and 30th minutes of all children taken to the recovery unit in the postoperative period will be recorded by the recovery unit nurse. . Children who are thought to have pain according to the FLACC score will be given 0.5 mg/kg meperidine as rescue analgesia and a note will be taken.

Primary outcomes

  1. Anxiety level of parents

    Time frame: preoperative period

    It will be measured with STAI-I and STAI-II (State-Trait Anxiety Scale) scale forms.

  2. Anxiety level of the child undergoing surgery

    Time frame: preoperative and intraoperative period

    According to the m-YPAS (modified Yale Preoperative Anxiety) scale, children's anxiety levels will be calculated in the preoperative waiting room (T1) and when the anesthesia ventilation mask is shown (T4).

  3. Pain levels of children undergoing surgery

    Time frame: postoperative period

    Pain levels of all children taken to the recovery unit will be measured with the FLACC (Face, Legs, Activity, Cry, Consolabilityscale) score at the 5th, 10th, 20th and 30th minutes.

Secondary outcomes

  1. heart rate

    Time frame: intraoperative period

    beats/min

  2. heart rate

    Time frame: up to 8 hour postoperative

    beats/min

  3. complication

    Time frame: up to 24 hour postoperative

    such as nausea, vomiting and desaturation

Sponsors and collaborators

Lead sponsor

Giresun University

Other

Registry information

Official study title

The Relationship Between Pre-operative Parental Anxiety Level and the Child's Anxiety Level and Its Effect on Postoperative Pain in Children Aged 2-6 Years Who Will Undergo Inguinal Area Surgery.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 8, 2024
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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