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Aromaterapia en el reemplazo total de rodilla

29 de octubre de 2026 actualizado por: Hospital for Special Surgery, New York

Aromatherapy for Post-operative Anxiety and Pain After Primary Unilateral Total Knee Replacement: A Pilot Randomized Controlled Trial

The purpose of this pilot randomized controlled trial is to investigate the effects of aromatherapy on postoperative anxiety and pain in total knee replacement patients. The primary research questions are:

Does Lavender-Peppermint Aromatherapy reduce post operative anxiety in patients after primary total knee replacement when compared to placebo?

Does Lavender-Peppermint Aromatherapy reduce post operative pain in patient after primary total knee replacement when compared to placebo?

Participants will be assigned to one of the following groups at random:

  • Intervention: Aromatherapy with the lavender-peppermint scent
  • Control: Aromatherapy with the almond oil scent

Participants will also be asked to complete pre- and post-operative questionnaires.

Researchers will compare both groups (intervention vs control) to see if aromatherapy reduces post-operative anxiety and/or pain.

Descripción general del estudio

Descripción detallada

Preoperative depression, anxiety, and catastrophizing have all been linked to an increase in postoperative pain and opiate use. Although aromatherapy, specifically lavender, may lower anxiety, no placebo-controlled trial has been undertaken to establish Aromatherapy's therapeutic promise for anxiety after total knee replacement. Although peppermint has been demonstrated to reduce nausea and vomiting, it has not been tested in this population for post-operative nausea and vomiting (PONV). The purpose of this pilot randomized controlled study is to determine the effectiveness of Lavender-Peppermint in reducing post-operative anxiety and discomfort in patients following unilateral primary knee replacement surgery.

The primary research questions are:

Does Lavender-Peppermint Aromatherapy reduce post operative anxiety in patients after primary total knee replacement when compared to placebo?

Does Lavender-Peppermint Aromatherapy reduce post operative pain in patient after primary total knee replacement when compared to placebo?

Participants will be assigned to one of the following groups at random:

  • Intervention: Aromatherapy in the lavender-peppermint scent
  • Control: Aromatherapy in the almond oil scent

Participants will also be asked to complete pre- and post-operative questionnaires via the following surveys/questionnaires:

  • State-Trait Anxiety Inventory Short Form
  • PROMIS Anxiety v1.0 (short form 8a)
  • PROMIS Depression v1.0 (short form 8a)
  • PROMIS Pain Interference v1.1 (short form 6b)
  • Pain Catastrophizing Scale
  • Pain Rating Scale in Numeric Form
  • Opioid Consumption
  • Opioid Related Symptoms Distress Scale
  • Adverse Events
  • Aromatherapy Satisfaction Questionnaire
  • Bang Blinding Index

Researchers will compare both groups (intervention vs control) to see if aromatherapy reduces post-operative anxiety and/or pain.

Tipo de estudio

Intervencionista

Inscripción (Actual)

30

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • New York
      • New York, New York, Estados Unidos, 10021
        • Hospital for Special Surgery

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Age > 18 and ≤ 80
  • Scheduled to undergo primary, unilateral knee replacement surgery
  • Willing and able to provide informed consent
  • Willing and able to complete follow-up procedures
  • Intact olfactory function
  • Score 19 or greater on the PROMIS Anxiety Shortform 8A

Exclusion Criteria:

  • Score <19 on the PROMIS Emotional Distress - Anxiety - Short Form 8a
  • Current major anxiety or depression
  • Currently taking medications to treat anxiety
  • Impaired sense of smell
  • History of chronic pain with opioid use for greater than 3 months
  • History of Drug or Alcohol abuse
  • History of fibromyalgia
  • History of G6PD deficiency
  • Plant or tree nut allergy
  • Severe allergy to Opioids, NSAIDS or local anesthetics (such as anaphylaxis)
  • Severe liver disease, renal insufficiency (with inability to take acetaminophen or NSAIDS)
  • Non-English Speaking
  • Surgery requiring a hospitalization of greater than 3 days
  • Patient refusal
  • Current cardiac fibrillation
  • Chronic opioid user (>3 months)
  • BMI ≥ 45
  • Contraindication to neuraxial anesthesia

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Lavender-Peppermint Aromatherapy Group

This is the interventional group. Participants in this group will receive aromatherapy tabs in the scent of lavender-peppermint. Tabs will be worn on a badge for a total of 72 hours, and participants will replace the aroma tabs every 12 hours.

100% pure essential oils Lavender-peppermint aromatabs purchased through Beekley Medical

Comparador de placebos: Almond-oil Aromatherapy Group

This is the placebo group. Participants in this group will receive aromatherapy tabs in the scent of almond oil. Tabs will worn on a badge for a total of 72 hours, and participants will replace the aroma tabs every 12 hours.

100% pure essential oils Almond-oil aromatabs purchased through Beekley Medical

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
State Trait Anxiety Inventory
Periodo de tiempo: Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7

To assess the change in participants' anxiety level before and each individual day after surgery. Measured using the State-Trait Anxiety Inventory (STAI).

STATE anxiety, with higher scores being worse:

For calm, at ease, relaxed, steady:

4 = not at all 3 = somewhat 2 = moderately so

1 = very much so

For tense, worrying over misfortunes, frightened, nervous, jittery, worried:

  1. = not at all
  2. = somewhat
  3. = moderately so
  4. = very much so

TRAIT anxiety, with higher scores being worse:

For self satisfaction, feeling secure, being steady:

4=almost never 3=sometimes 2=often

1=almost always

For nervous/restless, wishing to be happier, feeling like a failure, worrying too much, lacking self confidence, feeling inadequate, feeling tension:

  1. almost never
  2. sometimes
  3. often
  4. almost always

STAI is scored as a sum of the scores for state and trait, with 20 being the lowest score (better outcome) and 80 being the highest score (worse outcome).

Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 8a Version 1.0
Periodo de tiempo: Measured pre-operatively and on post-operative day (POD) 7

To assess participants' preoperative (cumulative 7 days before surgery) and postoperative (cumulative 7 days after surgery) anxiety. Measured using the PROMIS anxiety short form 8a Version 1.0. Scored on the following scale:

  1. = never
  2. = rarely
  3. = sometimes
  4. = often
  5. = always with 1 being the lowest score and 5 being the highest scores.

PROMIS anxiety short form 8a Version 1.0 is scored by calculating the sum of the scores for each question, and using the PROMIS conversion matrix to report the T-score (The T-score is a standardized metric where the United States general population mean is set to 50 with a standard deviation (SD) of 10. Higher T-scores indicate greater levels of anxiety.)

Measured pre-operatively and on post-operative day (POD) 7
Numeric Rating Scale Pain Scores
Periodo de tiempo: Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7

To assess the average pain score of participants after surgery. Measured using the numerical rating scale (NRS). Measured on a 11-point numeric scale from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

Measured pre-operatively, in the post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form 8a
Periodo de tiempo: Measured pre-operatively and on post-operative day (POD) 7

To assess participants' post-operative emotional distress. Measured using the PROMIS depression short form 8a. Scored on the following scale:

  1. = never
  2. = rarely
  3. = sometimes
  4. = often
  5. = always with 1 being the lowest score and 5 being the highest scores.

Scored by calculating the sum of the scores for each question, and using the PROMIS conversion matrix to report the T-score. (The T-score is a standardized metric where the United States general population mean is set to 50 with a standard deviation (SD) of 10. Higher T-scores indicate greater levels of anxiety.)

Measured pre-operatively and on post-operative day (POD) 7
Pain Catastrophizing Scale
Periodo de tiempo: Measured pre-operatively, post-operative day (POD) 1, POD 2, POD 3, POD 7

The Pain Catastrophizing Scale is made up of 13 phrases that describe various thoughts and sensations that people may have while they are in pain. The items are assessed on a 5-point scale and are grouped into three categories: rumination (4 questions), magnification (3 questions), and helplessness (6 questions). Scored on the following scale:

0 = Not at all

  1. = To a slight degree
  2. = To a moderate degree
  3. = To a great degree
  4. = All the time with 0 being the lowest and 4 being the highest score.

Scored as the sum of all questions, and the sum of the scores for each question within each subscale. The range for Total Sum: 0 to 52, Rumination: 0 to 16, Magnification: 0 to 12, Helplessness: 0 to 24

Measured pre-operatively, post-operative day (POD) 1, POD 2, POD 3, POD 7
Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v1.1 Pain Interference
Periodo de tiempo: Measured pre-operatively and on post-operative day (POD) 7

The PROMIS SF v1.1 Pain Interference instruments (adult) measure the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Pain Interference also incorporates items probing sleep and enjoyment in life, though the item bank only contains one sleep item. The Pain Interference items utilize a 7-day recall period (items include the phrase "the past 7 days"). Scored on the following scale:

  1. = Not at all
  2. = A little bit
  3. = Somewhat
  4. = Quite a bit
  5. = Very much With 1 being the lowest and 5 being the highest

Scored by calculating the sum of the scores for each question, and using the PROMIS conversion matrix to report the T-score. (The T-score is a standardized metric where the United States general population mean is set to 50 with a standard deviation (SD) of 10. Higher T-scores indicate greater levels of anxiety.)

Measured pre-operatively and on post-operative day (POD) 7
Post-operative Opioid Consumption
Periodo de tiempo: Measured in the post-operative care unit (PACU), post-operative day (POD) 1, POD2, POD3, POD7

Self-reported measure of medication, dosage, and time of opioid consumption. Reported as Morphine Milligram equivalents.

Measured in the post-operative care unit (PACU), post-operative day (POD) 1, POD2, POD3, POD7
Number of Participants With Post-operative Nausea
Periodo de tiempo: Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7

To assess if participants experience post-operative nausea. Measured using the Opioid Related Symptom Distress Scale question: In the past 24 hours, I had nausea (yes/no).

Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
Number of Participants With Post-operative Vomiting
Periodo de tiempo: Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7

To assess if participants experience post-operative vomiting. Measured using the Opioid Related Symptom Distress Scale question: In the past 24 hours, I had vomiting (yes/no).

Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
Incidences of Post-operative Complications
Periodo de tiempo: Measured at post-anesthesia care unit (PACU) up to post operative day 7

To assess the incidences of post-operative complications such as need for ICU admission, DVT/PE, MI, stroke.

To be measured in the number of patients who reported adverse events.

Measured at post-anesthesia care unit (PACU) up to post operative day 7
Opioid-related Symptom Distress Scale
Periodo de tiempo: Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7

The Opioid-Related Symptom Distress Scale (ORSDS) assesses opioid-related symptoms across the dimensions of frequency, severity, and bothersomeness. According to the scoring manual, Clinically Meaningful Events (CMEs) are calculated using the symptom severity items only. Severity is rated on a 5-point scale ranging from 0 (did not have symptom) to 4 (very severe). Therefore, scores range from 0 to 4, with higher scores indicating greater symptom severity.

Measured at post-anesthesia care unit (PACU), post-operative day (POD) 1, POD 2, POD 3, POD 7
Participants' Satisfaction With the Aromatherapy
Periodo de tiempo: Measured at post operative day 7

Self-reported responses on a survey of 7-items to assess participants' level of satisfaction with the aromatherapy they received.

Measured on the following scales:

  1. = Not satisfied/no prior knowledge or experience/ not at all/ no
  2. = A little bit/a little knowledge or experience/to a slight degree
  3. = Moderately/moderate knowledge or experience/to a moderate degree
  4. = Quite a bit/considerable knowledge or experience/to a great degree
  5. = Extremely satisfied/expert knowledge or regular application/all of the time/ yes with 1 being the lowest and 5 being the highest.
Measured at post operative day 7
Aromatab Adherence
Periodo de tiempo: Measured on post operative day (POD) 1, POD2, POD3.

Feasibility was assessed as the number of Participants that reported "Yes" to wearing each aromatab.

Measured on post operative day (POD) 1, POD2, POD3.
Hospital Length of Stay
Periodo de tiempo: Measured at discharge as number of hours elapsed between post anesthesia care unit entry and discharge time

Hospital length of stay was measured as hours elapsed from post anesthesia care unit entry to discharge, assessed up to 7 days.

Measured at discharge as number of hours elapsed between post anesthesia care unit entry and discharge time
Bang Blinding Index
Periodo de tiempo: Measured on postoperative day 7

The Bang Blinding Index ranges from -1 to 1, where index of 0 indicates random guessing (perfect blinding, better outcome), 1 indicates complete unblinding (all guesses are correct, worse outcome), and -1 indicates complete opposite guessing (all guesses are incorrect, worse outcome). Patients were asked to guess whether the patient was given the intervention (Lavender-Peppermint) or Control (Almond Oil) Aromatherapy. For each arm, calculation of the index score involves subtracting the proportion of respondents assigned to that arm who guess incorrectly from the proportion that guessed correctly.

Measured on postoperative day 7

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Uchenna Umeh, MD, Hospital for Special Surgery, New York

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

3 de octubre de 2023

Finalización primaria (Actual)

1 de abril de 2024

Finalización del estudio (Actual)

1 de abril de 2024

Fechas de registro del estudio

Enviado por primera vez

13 de septiembre de 2023

Primero enviado que cumplió con los criterios de control de calidad

13 de septiembre de 2023

Publicado por primera vez (Actual)

21 de septiembre de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de octubre de 2026

Última verificación

1 de enero de 2025

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

There is no plan to make IPD available to other researchers.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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