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- Essai clinique NCT07930455
Cold Therapy Following Laparoscopic Cholecystectomy
The Effect of Cold Application to the Trocar Incision After Laparoscopic Cholecystectomy on Pain, Sleep Quality, and Quality of Postoperative Recovery
Non-pharmacological methods used to reduce a patient's pain after surgery are important complementary approaches that allow pain to be managed without the potential side effects of medications. Controlling pain in the postoperative period reduces pain-related anxiety in patients, prevents adverse outcomes, facilitates early mobilization, and increases patient comfort and satisfaction, thereby reducing the risk of postoperative complications. It also accelerates recovery, shortens the length of hospital stay, and reduces hospital costs. For these reasons, the use of non-pharmacological pain management following surgical procedures yields positive outcomes for the patient. No study has been found in the literature that measures the effect of cold application-one of the non-pharmacological methods used to alleviate pain in patients following laparoscopic cholecystectomy-on patients' sleep quality and quality of recovery. For this reason, this study is designed to determine the effects of cold therapy applied to the trocar incision site following laparoscopic cholecystectomy on pain, sleep quality, and the quality of postoperative recovery.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
As with all surgical procedures, patients experience acute pain following laparoscopic cholecystectomy. This pain directly affects patients' daily activities, emotional well-being, sleep quality, physical mobility, eating habits, stress levels, recovery process, and overall quality of life. Pain following laparoscopic cholecystectomy reduces patient comfort and satisfaction; it lowers quality of life by leading to undesirable conditions such as insomnia due to stress caused by postoperative pain, and it negatively affects postoperative recovery. Analgesics and opioids are commonly used in clinical settings to manage pain in patients following laparoscopic cholecystectomy. However, long-term use of pharmacological methods can lead to side effects such as nausea and vomiting, respiratory depression, and the development of allergies, and may delay wound healing following the surgical procedure. In addition, the long-term use of pharmacological methods leads to a gradual increase in analgesic dosage and increased opioid dependence in patients, resulting in longer hospital stays and higher costs. Non-pharmacological methods used to reduce a patient's pain after surgery are important complementary approaches that allow pain to be managed without the potential side effects of medications. Controlling pain in the postoperative period reduces pain-related anxiety in patients, prevents adverse outcomes, facilitates early mobilization, and enhances patient comfort and satisfaction, thereby reducing the risk of postoperative complications. It also accelerates recovery, shortens the length of hospital stay, and reduces hospital costs. For this reason, the use of non-pharmacological pain management after surgery yields positive outcomes for the patient.
Postoperative pain is the most common cause of sleep disturbances in patients. Patients who undergo surgery often experience significant sleep disturbances immediately following the procedure. A patient's ability to resume normal activities after surgery is an important indicator of the quality of postoperative recovery. While there are many tools available to measure the quality of postoperative recovery, in recent years, the concept of "quality of postoperative recovery"-as perceived by the patient and evaluated from the patient's perspective-has garnered significant attention. Recent studies emphasize the importance of assessing the quality of a patient's recovery during the postoperative period-including the patient's postoperative physiological well-being (consciousness, respiration, thermoregulation, and management of nausea and vomiting, etc.), length of hospital stay, and utilization of hospital resources. These studies have shown that evaluating the quality of postoperative recovery is beneficial across various surgical procedures.
The effective prevention and management of pain in patients following laparoscopic cholecystectomy are among the fundamental responsibilities of nurses as healthcare professionals. In this context, methods such as cold therapy, music therapy, acupressure, foot baths, foot massage, hand massage, shoulder massage, relaxation exercises, breathing exercises, transcutaneous electrical nerve stimulation, early mobilization, chewing gum, and aromatherapy are used to reduce pain in patients following laparoscopic cholecystectomy. Laparoscopic cholecystectomy affects the patient's pain and sleep quality. Due to pain, patients are unable to find a comfortable position, frequently change positions throughout the night, and experience increased analgesic requirements-all of which negatively affect their sleep quality. This cycle also directly impacts the quality of postoperative recovery. Therefore, pain, sleep, and recovery quality are three fundamental components that interact with one another during the postoperative period. While pain negatively affects sleep quality, poor-quality sleep increases pain sensitivity; both conditions delay physical and psychological recovery. Conversely, effective interventions that reduce pain can contribute to improved recovery quality by enhancing sleep quality. This reciprocal interaction demonstrates that nursing care following laparoscopic cholecystectomy should not focus solely on pain control but should also aim to preserve the patient's sleep pattern to improve sleep quality and support holistic recovery, thereby enhancing the patient's quality of recovery. No study has been found in the literature that measures the effect of cold application-one of the non-pharmacological methods used to alleviate pain in patients following laparoscopic cholecystectomy-on patients' sleep quality and quality of recovery. For this reason, this study is designed to determine the effects of cold therapy applied to the trocar incision site following laparoscopic cholecystectomy on pain, sleep quality, and the quality of postoperative recovery. Thus, the study will yield high-level evidence and provide information that can help address the gap in the literature in this field.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Merve İcat
- Numéro de téléphone: +905076532994
- E-mail: mervetpl97@gmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients who underwent elective laparoscopic cholecystectomy,
- Patients who are willing to communicate and cooperate,
- Patients aged 18-65,
- Patients who are alert, oriented, and cooperative,
- Patients who can read and understand Turkish,
- Patients with an ASA score of I or II,
- Patients who stayed in the hospital for at least one night following the surgical procedure,
- No history of medication use in the past 24 hours that could affect abdominal pain (nonsteroidal anti-inflammatory drugs, analgesics),
- No history of a physician-diagnosed sleep disorder (insomnia, obstructive sleep apnea syndrome, restless legs syndrome, narcolepsy, etc.),
- Not regularly using medications or supplements that affect sleep patterns (hypnotics, sedatives, melatonin),
- Patients with no history of any psychiatric illness or mental disorder diagnosed by a physician,
- Patients who do not use psychotropic medications that may affect sleep quality (such as antidepressants, antipsychotics, or anxiolytics),
- Patients who have signed the "Voluntary Informed Consent Form" will be included.
Exclusion Criteria:
- Those who underwent emergency laparoscopic cholecystectomy,
- Those scheduled for open cholecystectomy,
- Those unwilling to communicate or cooperate,
- Those under 18 or over 65 years of age,
- Unconscious, disoriented, or uncooperative,
- Unable to read and understand Turkish,
- For whom written and verbal consent to participate in the study could not be obtained,
- With an ASA score of III or higher,
- Discharged on the same day following the surgical procedure,
- With sensitivity to cold,
- Who have any psychiatric illness or mental disorder diagnosed by a physician,
- Who are taking psychotropic medications that may affect sleep quality, such as antidepressants, antipsychotics, or anxiolytics,
- Who have a history of taking medications that may affect abdominal pain within the last 24 hours (NSAIDs, analgesics),
- Patients with a history of a sleep disorder diagnosed by a physician (insomnia, obstructive sleep apnea syndrome, restless legs syndrome, narcolepsy, etc.),
- Patients who regularly use medications or dietary supplements that affect their sleep patterns (hypnotics, sedatives, melatonin) will not be included.
Excluded from the study:
- Patients who do not wish to continue cold therapy for any reason,
- Patients in whom the procedure was converted from laparoscopic cholecystectomy to open cholecystectomy during surgery,
- Patients who developed complications during or after the surgical procedure,
- Patients who were monitored in the intensive care unit following laparoscopic cholecystectomy,
- Patients who did not perform cold therapy regularly will be excluded.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Cold therapy
Patients in the study group will receive cold therapy using an ice pack for 20 minutes every hour, starting from the first hour after laparoscopic cholecystectomy and continuing for the first 8 hours. Once the patient regains consciousness after the surgical procedure, they will be informed, and the Demographic and Clinical Characteristics Form will be completed during the first hour; the patient will then be assessed according to the VAS and Cold Therapy Chart. Since skin temperature must drop below 13.6 °C for cold therapy to have a local analgesic effect, the patient's skin temperature will be measured every five minutes during the cold therapy session, and the application will be discontinued when it reaches 13.6 °C. Following cold application, the investigator will re-evaluate patients using the VAS and the Cold Application Chart at 1, 8, and 24 hours. Patients will be asked to complete the "Richard-Campbell Sleep Scale" and the (QoR-15) after surgery. |
Patients in the study group will receive cold therapy using an ice pack for 20 minutes every hour, starting from the first hour after laparoscopic cholecystectomy and continuing for the first 8 hours. Once the patient regains consciousness after the surgical procedure, they will be informed, and the Demographic and Clinical Characteristics Form will be completed during the first hour; the patient will then be assessed according to the VAS and Cold Therapy Chart. Since skin temperature must drop below 13.6 °C for cold therapy to have a local analgesic effect, the patient's skin temperature will be measured every five minutes during the cold therapy session, and the application will be discontinued when it reaches 13.6 °C. Following cold application, the investigator will re-evaluate patients using the VAS and the Cold Application Chart at 1, 8, and 24 hours. Patients will be asked to complete the "Richard-Campbell Sleep Scale" and the (QoR-15) after surgery. |
|
Aucune intervention: control group
Patients in the control group, however, will receive the clinic's routine treatment and nursing care without any additional interventions. At the clinic where the study will be conducted, when patients return to their rooms following laparoscopic cholecystectomy, they are administered the analgesics prescribed by the physician [paracetamol (1000 mg/100 ml) and/or ketavel (50 mg/2 ml) and/or pethidine hydrochloride (100 mg/2 ml)] are administered, and the patient is placed on strict bed rest for six hours. After six hours, patients are encouraged to walk, and oral intake is initiated. At the clinic, no non-pharmacological methods are used to reduce pain in patients following laparoscopic cholecystectomy. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from Baseline in the Pain
Délai: In patients following cold therapy, at 1, 8, and 24 hours
|
Visual Analog Scale (VAS): This form examines patients' demographic and clinical characteristics; it includes information on the patient's age, gender, educational status, and whether analgesics were administered following laparoscopic cholecystectomy, as well as the type and dosage if administered. |
In patients following cold therapy, at 1, 8, and 24 hours
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Sleep Quality
Délai: The morning after the first night following surgery
|
Richard-Campbell Sleep Scale: Developed by Richards in 1987, this sleep scale consists of six items that assess the depth of nighttime sleep, the time taken to fall asleep, the frequency of awakenings, the duration of wakefulness after waking, sleep quality, and the noise level in the environment. Özlü and Özer conducted a validity and reliability study of the scale in Turkey in 2015. Each item is rated on a scale from 0 to 100 using the visual analog scale technique. On the scale, a score between "0 and 25" indicates very poor sleep, while a score between "76 and 100" indicates very good sleep. The total score is calculated based on the first five items, and the sixth item-which assesses ambient noise levels-is excluded from the total score calculation. Patients' sleep quality improves as their score on the scale increases. While the Cronbach's α value of the original scale is 0.82, that of the Turkish version is 0.91. |
The morning after the first night following surgery
|
|
Postoperative Quality of Recovery Scale
Délai: Before the patient is discharged following surgery
|
Quality of Recovery-15 (QoR-15): The QoR-15 was developed in 2013 as a revised and abbreviated version of the QoR-40 to assess the quality of recovery following surgery and anesthesia. This unidimensional scale is designed to assess patients' quality of recovery and well-being in the early postoperative period. It consists of a 15-item questionnaire that evaluates the patient's physical comfort, physical independence, emotional state, psychological support, and pain status. For each question on the QoR-15, the patient is asked to rate their level of recovery on a scale from 0 to 10. Once all responses are collected, a total score ranging from 0 to 150 is calculated. A total score between 136 and 150 indicates excellent recovery; between 122 and 135, good recovery; between 90 and 121, moderate recovery; and between 0 and 89, poor recovery. Validity and reliability studies of the Turkish version of the QoR-15 were conducted by Selvi et al., and Cronbach's α was found to be 0.928. |
Before the patient is discharged following surgery
|
|
Cold Application Chart
Délai: In patients following cold therapy, at 1, 8, and 24 hours
|
Cold Application Chart: Data regarding the timing of cold application to the trocar incision in the abdominal region, skin surface temperature before and after cold application, and the pre- and post-application temperatures of the cold application material (ice pack) will be recorded. |
In patients following cold therapy, at 1, 8, and 24 hours
|
Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 30/09/2026 2026/606
Informations sur les médicaments et les dispositifs, documents d'étude
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