An interventional study of Chewing Gum in Laryngeal Mask, Throat Pain and Anxiety, sponsored by Ankara Medipol University. Enrolling by invitation at 2 sites in Turkey. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-26.
Sponsored by Ankara Medipol University · Not applicable, Interventional, and Prevention
This study was planned to investigate the effect of chewing gum in the preoperative period on patients' sore throat and anxiety levels.
Postoperative sore throat is a common complaint (1,2). It is reported in the literature that there are various pharmacological methods to reduce this condition, such as the use of nebula, corticosteroids, nonsteroidal anti-inflammatory drugs, or lidocaine. However, these methods have various advantages and disadvantages (3,4). Chewing gum, one of the non-pharmacological methods may be safer for the patient. Chewing gum increases salivary gland secretion and provides lubrication of the oral cavity (5). For this reason, it was thought that chewing gum before surgery could reduce throat pain after using a laryngeal mask due to the effect it provides. It has been determined that there are few experimental studies on the subject in the literature (6,7).
The presence of preoperative anxiety may lead to an increase in the need for intraoperative anesthesia and analgesic consumption in the postoperative period (8,9). However, it may cause a decrease in patient satisfaction and prolong the recovery process in the postoperative period (8,9). Pharmacological approaches can be applied to address this concern. However, non-pharmacological approaches may be safer for patients. Chewing gum during this process can also reduce patients' anxiety levels. A sufficient number of studies on the subject could not be found (10).
The study will conduct as a prospective randomized controlled trial. After obtaining verbal and written consent from the patients before and after the surgery, the study will conduct with various data collection forms.
These forms are; patient Identification form, Amsterdam Preoperative Anxiety and Information Scale (APAIS), Visual Analogue Scale (VAS). Patients will randomize. The chewing gum group in group- I (n=46), and group II (n=46) will be the control group. We have two stage.In first stage; anxiety levels will be measured for both group. In second stage; throat pain will evaluated at 2.-4.-6. hours.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 92 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Ankara Medipol University is the lead sponsor of 56 studies on the registry; 10 are open to participants now.
Compared within Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pharyngitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Using cigarette
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before the surgery, the patient will chew gum for 2 minutes and routine nursing care will be applied. Anxiety level will be evaluated before and after chewing gum.
Other: Chewing Gum
Anxiety level will be evaluated before and after routine nursing care.
The patient will be asked to chew gum before the surgery during the 2 minutes. Anxiety level will evaluated before and after chewing gum.
Change from preoperative anxiety level in a 2 minutes
In this section, the anxiety level will decrease or disappear. This status will evaluate with Amsterdam Preoperative Anxiety and Information Scale (APAIS). APAIS consists of two scales, including a four-item anxiety scale and two-items information requirement. Items are rated on a Likert scale from 1 ("not at all worried") to 5 ("very worried"). The score ranges for the anxiety subscale and the information need subscale are 4-20 and 2-10, respectively. High scores are associated with higher levels of anxiety and need for information. Cronbach's α coefficients for the anxiety subscale and the information need subscale were 0.86 and 0.68, respectively (Moerman et al.1996). Çetinkaya et al. The validity and reliability of the Turkish translation of APAIS was verified in 2019. Cronbach's α coefficients of the APAIS anxiety and information need subscales were 0.897 and 0.786, respectively
Time frame: After chewing gum for 2 minutes
Change from postoperative throat pain level at 2., 4., 6. hours
In this section, the degree of postoperative throat pain level will decrease or disappear. This status will evaluate with Visual Analogue Scale (VAS). VAS is a horizontal line with a length of 10 cm. According to VAS, 0 is the lowest level and 10 is the highest level.
Time frame: Time frame: Postoperative time at 2., 4., 6., hours
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Ankara Medipol University