The Effect of Preoperative Abdominal Massage on Postoperative Constipation
The Effect of Preoperative Abdominal Massage on The Development of Postoperative Constipation: A Randomised Controlled Study
The aim of this clinical study is to determine whether preoperative abdominal massage has an effect on the development of postoperative constipation. The main questions it aims to answer are:
• Does preoperative abdominal massage improve postoperative stool consistency? • Does preoperative abdominal massage prevent constipation? To see if abdominal massage is effective in preventing constipation, researchers will not apply any treatment to the second group and will compare the two groups.
Participants will:
- Provide researchers with information about their preoperative and postoperative stool consistency and constipation status.
- Inform the researchers if the group that received the massage experiences any adverse effects from the massage.
Panoramica dello studio
Descrizione dettagliata
Abdominal massage, being a low-cost, non-invasive procedure with no known harmful side effects, and one that nurses can integrate into clinical practice, plays an important role in the management of constipation.
This study is a single-center, randomized controlled experimental trial planned to be conducted in the General Surgery Department of a Training and Research Hospital in Istanbul. Standard operating procedures for patient recruitment, data collection, data management, adverse event reporting, and change management processes have been predefined. The experimental group will receive abdominal massage twice daily for 15 minutes, while the control group will continue with routine care. Adverse events will be recorded after each session, and necessary protocol changes will be documented in accordance with formal change management procedures. The sample size was determined based on a power analysis performed with G*Power 3.1; 30 participants were planned for each group (total n=60; α=0.05, power=0.80). A complete case analysis approach will be adopted for missing data resulting from data inconsistencies, out-of-range results, or unanswered items, and group assignments will continue until data is complete. In accordance with the statistical analysis plan, the Mann-Whitney U test will be used for between-group comparisons and the Wilcoxon test for within-group comparisons for the Bristol Stool Scale (BSS) score, which is the primary outcome measure; For the secondary outcome measure, stool type distribution, the Chi-square test will be applied. Effect size will be reported using Cohen's d and odds ratio, and the statistical significance threshold will be set at p<0.05.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Istanbul
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Istanbul, Istanbul, Turchia (Türkiye)
- Health Sciences University Sultan Abdülhamid Han Training and Research Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion criteria:
- Being hospitalized in the General Surgery Department
- Experiencing constipation
- Being 18 years of age or older
- Having the cognitive ability to answer questions
- Voluntary participation in the study
Exclusion criteria:
- Being under 18 years of age
- Not experiencing constipation
- Having a condition that contraindicates abdominal massage (active intra-abdominal pathology, open wound, thrombocytopenia, etc.)
- Insufficient cognitive ability
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Nessun intervento: Gruppo di controllo
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Sperimentale: Abdominal Massage İnterventional Group
Massage Group
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The procedure will be followed using a protocol prepared by researchers based on a literature review.
Massage sessions are scheduled for 10:00 AM and 4:00 PM, 30 minutes after a meal.
The massage duration is 15 minutes.
The frequency of massage is twice a day.
Necessary tools and equipment include liquid petroleum jelly and a towel.
The massage techniques include effleurage (superficial and deep), petrissage, and vibration.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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BSS score
Lasso di tempo: BSS score preoperative period and postoperative 24. hour
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According to the Bristol Stool Scale, a score of 1-2 indicates "hard stools," 3-4-5 indicates "normal stools," and 6-7 indicates "soft-watery stools (diarrhea)."
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BSS score preoperative period and postoperative 24. hour
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Stool type distribution/constipation
Lasso di tempo: preoperative period and postoperative 24. hour
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Stool type: hard/normal
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preoperative period and postoperative 24. hour
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- McClurg D, Lowe-Strong A. Does abdominal massage relieve constipation? Nurs Times. 2011 Mar 29-Apr 4;107(12):20-2.
- Celik S, Atar NY, Ozturk N, Mendes G, Kuytak F, Bakar E, Dalgiran D, Ergin S. Constipation risk in patients undergoing abdominal surgery. Iran Red Crescent Med J. 2015;17(6):e23632. doi: 10.5812/ircmj.23632
- 1. Olgun S, Eser I. The effect of abdominal massage on chronic constipation and constipation quality of life in elderly: a randomized controlled trial. Int J Med Res Health Sci. 2021;10(6):20-30.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 24/11/2022-984
Piano per i dati dei singoli partecipanti (IPD)
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Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
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