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IRCT20250726066642N3 IRCT 2026-04-22 Tabriz University of Medical Sciences The Effect of Aromatherapy on Pain and Anxiety Comparison the effect of lavender and rose aroma on children's pain and anxiety after surgery: A controlled randomized clinical trial. 2026-05-15 anticipated 111 Complete https://irct.ir/trial/89542 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples will be selected from all patients admitted to the surgical ward who have undergone appendectomy using the convenience sampling method. Then, eligible children will be randomly assigned using a block randomization method (four and six blocks) into one of three groups (lavender scent, Damask rose scent, and control). Opaque, sealed envelopes will be used to conceal the sequence of children's allocation to the groups, Blinding description: In this study, blinding of the principal investigator and intervention recipients was not achievable. However, the data analyst (research assistant) is blinded to the group allocation of the children. N/A pain and anxiety. Intervention 1: Intervention group1: After being transferred from the recovery room to the surgical ward, the patient will receive routine care. Then, using the Ochre tool, the child will be asked to rate their pain level from zero to 10 or choose a similar image. The level of anxiety will also be scored by the researcher using the OSBD-R tool. Next, the necklace containing 5 drops of the first scent (lavender essential oil made by Ellis Company with health code 36/13365) will be hung around the child's neck by the researcher to inhale the scent. The necklace is made of soft, porous yarn and mesh, which is completely hygienic and hypoallergenic, and its length can be adjusted to be at a safe and appropriate distance from the nose and mouth. The parents/carers will be instructed on how to keep the necklace on the chest and avoid moving or manipulating it. Three hours after the first measurement, the child's pain will be scored using the Ochre tool and anxiety will be scored using the OSBD-R tool. For proper efficacy and to prevent normalization of the inhaled odor, the odor is renewed and again 3 hours later (6 hours after the first measurement) pain will be scored using the Ochre tool and anxiety will be scored using the OSBD-R tool. The number of drops and the intervals of patient assessment for pain and anxiety are modeled according to previous similar studies conducted on pediatric populations. Intervention 2: Intervention group2: After being transferred from the recovery room to the surgical ward, the patient will receive routine care. Then, using the Ochre tool, the child will be asked to rate their pain level from zero to 10 or choose a similar image. The level of anxiety will also be scored by the researcher using the OSBD-R tool. Next, the necklace containing 5 drops of the second scent (Rose flower drop made by Ellis Company with health code 36/13365) will be hung around the child's neck by the researcher to inhale the scent. The necklace is made of soft, porous yarn and mesh, which is completely hygienic and hypoallergenic, and its length can be adjusted to be at a safe and appropriate distance from the nose and mouth. The parents/carers will be instructed on how to keep the necklace on the chest and avoid moving or manipulating it. Three hours after the first measurement, the child's pain will be scored using the Ochre tool and anxiety will be scored using the OSBD-R tool. For proper efficacy and to prevent normalization of the inhaled odor, the odor is renewed and again 3 hours later (6 hours after the first measurement) pain will be scored using the Ochre tool and anxiety will be scored using the OSBD-R tool. The number of drops and the intervals of patient assessment for pain and anxiety are modeled according to previous similar studies conducted on pediatric populations. Intervention 3: Control group: After being transferred from the recovery room to the surgical ward, the patient will receive routine care. Then, using the Ochre tool, the child will be asked to rate their pain level from zero to 10 or choose a similar image. The level of anxiety will also be scored by the researcher using the OSBD-R tool. Next, the necklace containing 5 drops of distilled water will be hung around the child's neck by the researcher to inhale the scent. The necklace is made of soft, porous yarn and mesh, which is completely hygienic and hypoallergenic, and its length can be adjusted to be at a safe and appropriate distance from the nose and mouth. The parents/carers will be instructed on how to keep the necklace on the chest and avoid moving or manipulating it. Three hours after the first measurement, the child's pain will be scored using the Ochre tool and anxiety will be scored using the OSBD-R tool. Three hours later (6 hours after the first measurement) pain will be scored using the Ochre tool and anxiety will be scored using the OSBD-R tool. The intervals of patient assessment for pain and anxiety are modeled according to previous similar studies conducted on pediatric populations. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Fatemeh Ghorbani
South Shariati, School of Nursing and Midwifery, Tabriz, Iran.
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 f.ghorbani2006@gmail.com Tabriz University of Medical Sciences scientific Fatemeh Ghorbani
South Shariati, School of Nursing and Midwifery, Tabriz, Iran.
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 f.ghorbani2006@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Age: 7 to 12 years old Underwent appendectomy surgery No history of psychological disorders based on the child’s medical record. No history of asthma or allergic rhinitis based on parental report. 7 years 12 years Both Need for post-operative oxygen therapy Patient deterioration post-surgery requiring intensive care Treatment - Drugs Treatment - Drugs Placebo Intervention group1: After being transferred from the recovery room to the surgical ward, the patient will receive routine care. Then, using the Ochre tool, the child will be asked to rate their pain level from zero to 10 or choose a similar image. The level of anxiety will also be scored by the researcher using the OSBD-R tool. Next, the necklace containing 5 drops of the first scent (lavender essential oil made by Ellis Company with health code 36/13365) will be hung around the child's neck by the researcher to inhale the scent. The necklace is made of soft, porous yarn and mesh, which is completely hygienic and hypoallergenic, and its length can be adjusted to be at a safe and appropriate distance from the nose and mouth. The parents/carers will be instructed on how to keep the necklace on the chest and avoid moving or manipulating it. Three hours after the first measurement, the child's pain will be scored using the Ochre tool and anxiety will be scored using the OSBD-R tool. For proper efficacy and to prevent normalization of the inhaled odor, the odor is renewed and again 3 hours later (6 hours after the first measurement) pain will be scored using the Ochre tool and anxiety will be scored using the OSBD-R tool. The number of drops and the intervals of patient assessment for pain and anxiety are modeled according to previous similar studies conducted on pediatric populations. Intervention group2: After being transferred from the recovery room to the surgical ward, the patient will receive routine care. Then, using the Ochre tool, the child will be asked to rate their pain level from zero to 10 or choose a similar image. The level of anxiety will also be scored by the researcher using the OSBD-R tool. Next, the necklace containing 5 drops of the second scent (Rose flower drop made by Ellis Company with health code 36/13365) will be hung around the child's neck by the researcher to inhale the scent. The necklace is made of soft, porous yarn and mesh, which is completely hygienic and hypoallergenic, and its length can be adjusted to be at a safe and appropriate distance from the nose and mouth. The parents/carers will be instructed on how to keep the necklace on the chest and avoid moving or manipulating it. Three hours after the first measurement, the child's pain will be scored using the Ochre tool and anxiety will be scored using the OSBD-R tool. For proper efficacy and to prevent normalization of the inhaled odor, the odor is renewed and again 3 hours later (6 hours after the first measurement) pain will be scored using the Ochre tool and anxiety will be scored using the OSBD-R tool. The number of drops and the intervals of patient assessment for pain and anxiety are modeled according to previous similar studies conducted on pediatric populations. Control group: After being transferred from the recovery room to the surgical ward, the patient will receive routine care. Then, using the Ochre tool, the child will be asked to rate their pain level from zero to 10 or choose a similar image. The level of anxiety will also be scored by the researcher using the OSBD-R tool. Next, the necklace containing 5 drops of distilled water will be hung around the child's neck by the researcher to inhale the scent. The necklace is made of soft, porous yarn and mesh, which is completely hygienic and hypoallergenic, and its length can be adjusted to be at a safe and appropriate distance from the nose and mouth. The parents/carers will be instructed on how to keep the necklace on the chest and avoid moving or manipulating it. Three hours after the first measurement, the child's pain will be scored using the Ochre tool and anxiety will be scored using the OSBD-R tool. Three hours later (6 hours after the first measurement) pain will be scored using the Ochre tool and anxiety will be scored using the OSBD-R tool. The intervals of patient assessment for pain and anxiety are modeled according to previous similar studies conducted on pediatric populations. Assessment of pain severity in pediatric patients who underwent appendectomy utilizing the Ocher pain assessment scale. Timepoint: The child's pain score will be assessed using a 0-10 numerical rating scale or a similar visual analog scale by the child, one hour post-surgery, and then at three and six hours after the initial measurement. Method of measurement: Ocher scale. Assessment of anxirty severity in pediatric patients who underwent appendectomy utilizing the OSBD-R scale (Observed Behavioral Distress Scale– Revise). Timepoint: Post-operative anxiety levels are assessed by the researcher during the first hour, then three hours and six hours from the first measurement. Method of measurement: OSBD-R scale (Observed Behavioral Distress Scale– Revise). Tabriz University of Medical Sciences Approved 2026-03-16 Ethics committee of Tabriz University of Medical Sciences Central Building No. 2, Third Floor, Vice-Chancellery for Research and Technology, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)