To assess the decrease in pain in neonates during painful procedures by making the mothers to hold their newborns, without using pain-relieving medications.

A Randomized Controlled Trial to assess the effect of providing facilitated tucking for pain management by simulation trained mothers vs nurses (routine care) on neonatal and maternal outcomes during selected painful procedures among preterm neonates admitted in neonatal units of PGIMER, Chandigarh. - NIL

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056592

Enrollment

110

Registered

2023-08-17

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Health Condition 1: G891- Acute pain, not elsewhere classified

Interventions

Intervention1: Facilitated tucking.: Facilitated tucking will be provided by simulated trained mothers to their preterm neonates during selected painful procedures. Control Intervention1: Routine car

Eligibility

Inclusion criteria

Inclusion criteria: All preterm neonates more than and equal to 35 weeks of the gestation age.

Exclusion criteria

Exclusion criteria: 1.Neonates who will be in shock. 2.Critically ill neonates. 3. Neonates who will be on sedative analgesics. 4. Neonates who will be getting drugs like morphine, midazolam which can cause CNS depression.

Design outcomes

Primary

Measure	Time frame
The level of pain will be decreased with facilitated tucking provided by mothers to their preterm neonates during selected procedures.Timepoint: 2 weeks after intervention.	—

Secondary

Measure	Time frame
The anxiety & stress level of mothers of the preterm neonates will be decreased when they will be participating in providing facilitated tucking during selected painful procedures.Timepoint: Stress & anxiety level of mothers of the preterm neonates will be checked after the selected painful procedures.;The stress & anxiety of mothers of the preterm neonates will be decreased when they will be participating in providing facilitated tucking during selected painful procedures.Timepoint: Stress & anxiety levels of mothers of the preterm neonates will be checked after the selected painful procedures.	—

Measure

Time frame

The anxiety & stress level of mothers of the preterm neonates will be decreased when they will be participating in providing facilitated tucking during selected painful procedures.Timepoint: Stress & anxiety level of mothers of the preterm neonates will be checked after the selected painful procedures.;The stress & anxiety of mothers of the preterm neonates will be decreased when they will be participating in providing facilitated tucking during selected painful procedures.Timepoint: Stress & anxiety levels of mothers of the preterm neonates will be checked after the selected painful procedures.

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Countries

India

Contacts

Public ContactMandeep Kaur Saini

Post Graduate Institute of Medical Education and Research.

geetss2@gmail.com9988854808

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026