Maternal Involvement in Pain Management in NICU : Maternal Involvement in Pain Management in NICU: a Randomized Controlled Trial
This study is a prospective, randomized controlled trial with a 2x2 crossover design. Study population include newborns admitted to NICU that require a heel stick procedure after the first week of life, mothers of enrolled infants and nurses performing the heel stick procedure. The sample size will be 50 newborns who meet the inclusion criteria. Newborns will be randomly assigned to receive: i) a heel stick procedure with maternal involvement and after a week an heel stick procedure without maternal involvement or ii) a procedure without maternal involvement and after a week a procedure with maternal involvement. For both group the washout period between the two procedures is 7 days.Before the intervention with the maternal involvement, mother will receive a training regarding the heel stick procedure and pain management.Research hypothesis:H1. Newborns receiving the intervention with the maternal involvement during the heel stick procedure have lower pain level than those who receive the intervention without the maternal involvement.H2. Mothers who are involved in their baby pain management during the heel stick procedure have lower level of stress, anxiety and depression than those who are not involved during the painful procedure.H3. Nurses have a positive effect in term of reducing stress level if mother is involved in pain management of own baby.PIPP (Premature Infant Pain Profile) scale will be used to evaluate the pain response during the heel stick procedure. The level of stress, anxiety and depression of mother and the stress level of nurse will be assessed with validated questionnaires..
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Klinische Studie| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
ClinicalTrials.gov - (2022) vom: 23. Mai Zur Gesamtaufnahme - year:2022 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: May 12, 2021, Last downloaded: ClinicalTrials.gov processed this data on May 30, 2022, Last updated: June 01, 2022 |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
CTG007619456 |
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| 245 | 1 | 0 | |a Maternal Involvement in Pain Management in NICU |b Maternal Involvement in Pain Management in NICU: a Randomized Controlled Trial |
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| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: May 12, 2021, Last downloaded: ClinicalTrials.gov processed this data on May 30, 2022, Last updated: June 01, 2022 | ||
| 520 | |a This study is a prospective, randomized controlled trial with a 2x2 crossover design. Study population include newborns admitted to NICU that require a heel stick procedure after the first week of life, mothers of enrolled infants and nurses performing the heel stick procedure. The sample size will be 50 newborns who meet the inclusion criteria. Newborns will be randomly assigned to receive: i) a heel stick procedure with maternal involvement and after a week an heel stick procedure without maternal involvement or ii) a procedure without maternal involvement and after a week a procedure with maternal involvement. For both group the washout period between the two procedures is 7 days.Before the intervention with the maternal involvement, mother will receive a training regarding the heel stick procedure and pain management.Research hypothesis:H1. Newborns receiving the intervention with the maternal involvement during the heel stick procedure have lower pain level than those who receive the intervention without the maternal involvement.H2. Mothers who are involved in their baby pain management during the heel stick procedure have lower level of stress, anxiety and depression than those who are not involved during the painful procedure.H3. Nurses have a positive effect in term of reducing stress level if mother is involved in pain management of own baby.PIPP (Premature Infant Pain Profile) scale will be used to evaluate the pain response during the heel stick procedure. The level of stress, anxiety and depression of mother and the stress level of nurse will be assessed with validated questionnaires. | ||
| 650 | 2 | |a Pain, Procedural | |
| 650 | 4 | |a Medical Condition: Procedural Pain, Mother-Infant Interaction, Infant, Newborn, Stress, Physiological | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Completed | |
| 650 | 4 | |a 610 | |
| 773 | 0 | 8 | |i Enthalten in |t ClinicalTrials.gov |g (2022) vom: 23. Mai |
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