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Rocking Motion: Physiologic Effect on the Surgical Stress Response

28 novembre 2017 mis à jour par: M.D. Anderson Cancer Center

After having abdominal surgery, patients often experience a lack of bowel function that can cause nausea, vomiting, abdominal swelling, pain, and/or discomfort. This is known as "post-operative ileus." Patients are usually not allowed to leave the hospital until their doctor is sure that their bowel function has returned.

The goal of this clinical research study is to compare using a rocking chair to the standard of care in improving post-operative ileus after abdominal surgery.

Aperçu de l'étude

Description détaillée

The standard method used to help the return of bowel function after surgery is to have patient get out of bed, sit in a chair for a period of time, and then begin walking the first day after surgery. Patients are then asked to increase the time they spend sitting in the chair and walking every day. However, it is not clear that this is the best method to assist in the return of normal bowel function. Some studies have shown that rocking in a rocking chair may help normal bowel function to return more quickly.

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group:

  • If you are in Group A, you will use the "rocking chair method." Beginning the first day after surgery, you will sit in a rocking chair and rock back and forth for 10-20 minutes at a time. This will be done for at least 60 minutes (1 hour) per day, until you pass gas for the first time after surgery. The study staff will show the correct method to rock in the rocking chair and give you time to practice while you are in the clinic.
  • If you are in Group B, you will use the standard method only. Beginning the first day after surgery, you will sit in a non-rocking chair for at least 60 minutes each day until you pass gas for the first time after surgery.

No matter what group you are in, you will also be asked to begin walking the first day after surgery until you pass gas for the first time after surgery.

You will wear an activity recorder all day attached to a wrist band in order to record your time spent in bed, in the rocking or non-rocking chair, and an activity monitor around your waist to record the time and distance walked during each 24-hour period. The study staff will show you how to wear this activity recorder. You will be encouraged by the study staff to increase the time spent in the chair and walking each day.

You will be given a pencil and pad of paper to note the date and time you first pass gas after surgery.

Study Tests:

On the day before you have surgery, the following tests and procedures will be performed:

  • You will be asked to provide demographic information (such as your age and marital status). This information will be coded to protect your privacy.
  • You will complete a questionnaire about any symptoms you may be experiencing. This should take about 10 minutes to complete.
  • Saliva will be collected to measure your cortisol level. For this saliva to be collected, you will spit into a tube. The level of cortisol in your saliva is used to measure your response to stress.

Every morning while you are in the hospital and until you pass gas for the first time after surgery:

  • You will be asked if you have passed gas.
  • Saliva will be collected to measure your cortisol level.
  • You will complete the symptom questionnaire.
  • It will take about ten minutes to complete the questionnaire and to collect the saliva sample.
  • You will perform the exercises described in the "Study Groups" section, depending on which group you are assigned to.

Length of Study:

You will be on study from the first day after surgery until you pass gas (usually about 3-5 days). You will be taken off study if you cannot tolerate rocking in a rocking chair, sitting in a non-rocking chair, or walking, due to discomfort or any other reason.

This is an investigational study. There are no additional costs to you for taking part in this study.

Up to 80 patients will take part in the study. All will be enrolled at MD Anderson.

Type d'étude

Interventionnel

Inscription (Réel)

86

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Texas
      • Houston, Texas, États-Unis, 77030
        • University of Texas MD Anderson Cancer Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. At least 18 years old
  2. Speak and read English
  3. Scheduled to undergo abdominal surgery
  4. Tolerate sitting in a rocking or nonrocking chair
  5. Able to ambulate
  6. Scheduled to receive epidural or intravenous patient controlled analgesia
  7. Cognitively intact
  8. Signed a study-specific informed consent prior to study entry
  9. May include patients undergoing ileostomy or colostomy reversal

Exclusion Criteria:

1) All others will be excluded.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Standard of Care Group
Post surgical patient to sit in a non-rocking chair for at least sixty minutes per day, and ambulating at least three times per day.
Post surgical patient to sit in a non-rocking chair for at least sixty minutes per day, and ambulating at least three times per day.
Beginning on day of surgery till discharge (3-5 days)
Autres noms:
  • Enquête
Expérimental: Rocking Motion Group
Post surgical patient to rock in a rocking chair in 10-20 minute increments for at least sixty minutes per day, and ambulating at least three times per day.
Beginning on day of surgery till discharge (3-5 days)
Autres noms:
  • Enquête
Post surgical patient to rock in a rocking chair in 10-20 minute increments for at least sixty minutes per day, and ambulating at least three times per day.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Efficacy of Rocking Chair Motion on Surgical-Induced Stress
Délai: 3 - 5 days
Efficacy of rocking chair motion on surgical-induced stress response as measured by salivary cortisol sample collected each morning in two groups of colon cancer patients recovering from abdominal surgery randomized to receive either a rocking chair motion intervention or standard care.
3 - 5 days

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Xin S. Wang, MD, MPH, M.D. Anderson Cancer Center

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 février 2012

Achèvement primaire (Réel)

20 novembre 2017

Achèvement de l'étude (Réel)

20 novembre 2017

Dates d'inscription aux études

Première soumission

9 septembre 2010

Première soumission répondant aux critères de contrôle qualité

10 septembre 2010

Première publication (Estimation)

13 septembre 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 novembre 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 novembre 2017

Dernière vérification

1 novembre 2017

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 2010-0129
  • NCI-2012-01884 (Identificateur de registre: NCI CTRP)
  • 10445215 (Autre subvention/numéro de financement: NINR)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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