UMIN-CTR Clinical Trial

Public title

Does tongue rotation exercise help to restore intestinal function after cesarean section ?

Acronym

Does tongue rotation exercise improve intestinal function?

Scientific Title

The effect of the tongue rotation exercise training for recovering intestinal function after cesarean delivery,a prospective ,randomized ,controlled trial.

Scientific Title:Acronym

The effect of the tongue rotation exercise training for recovering intestinal function after cesarean delivery

Region

Japan

Condition

Pregnant woman undergoing a cesarean section

Classification by specialty

Obstetrics and Gynecology	Anesthesiology	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Investigating the effects of tongue rotation exercises after cesarean section delivery on the timing of first farting, bowel sounds, defecation, incidence of ileus, and salivary amylase activity

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Time until first fart after cesarean section

Key secondary outcomes

Time to first normal bowel sound after cesarean section, time to first bowel movement, length of hospital stay, incidence of nausea and vomiting, incidence of ileus, presence or absence of abdominal distension as perceived by the patient, change in salivary amylase activity before and after first tongue-twisting exercise

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Perform the tongue rotation exercise below in the morning, at lunch time and in the evening, from 2 hours after the caesarean section to the first fart.

Interventions/Control_2

After the usual post-operative fasting period at our hospital, the patients will follow the diet for pregnant and nursing women (control group)

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

45

years-old

>=

Gender

Female

Key inclusion criteria

Patients scheduled to give birth by elective cesarean section at Kitasato University Hospital
Pregnant women aged 18 to 45 who have given consent to participate in the study and who had a scheduled cesarean section at our hospital during the second trimester of pregnancy

Key exclusion criteria

The following patients are excluded.
1 After an unplanned or emergency cesarean section
2 Cases involving surgical invasive procedures other than a normal cesarean section
3 Cases where blood products other than preoperative autologous blood were used for severe postpartum hemorrhage (>1500ml)
4 Cases where radiation therapy was performed for severe postpartum hemorrhage (>1500ml)
5 Those with a history of abdominal surgery during pregnancy
6 Those with a history of gastrointestinal disorders such as intestinal obstruction or inflammatory bowel disease, or peritonitis
7 After abdominal or pelvic radiation
8 Postoperative mechanical ventilation
9 Postoperative intensive care unit admission (excluding MFICU cases, GICU cases)
10 Patients with a history of opioid use
11 Patients who received ondansetron during cesarean section

Target sample size

60

Name of lead principal investigator

1st name	SHUNSUKE
Middle name
Last name	HYUGA

Organization

Kitasato University School of Medicine

Division name

Department of Anesthesiology

Zip code

2520375

Address

1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa Prefecture

TEL

0427788111

Email

shyuga@kitasato-u.ac.jp

Name of contact person

1st name	SHUNSUKE
Middle name
Last name	HYUGA

Organization

Kitasato University School of Medicine

Division name

Department of Anesthesiology

Zip code

252-0375

Address

1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0374, Japan

TEL

042-778-8111

Homepage URL

Email

shyuga@kitasato-u.ac.jp

Institute

Kitasato university

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kitasato University school of medicine, Institutional Review Board

Address

1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0374, Japan

Tel

042-778-8111

Email

rinrib@med.kitasato-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

09

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

60

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2022

Year

07

Month

27

Day

Date of IRB

2022

Year

07

Month

27

Day

Anticipated trial start date

2022

Year

09

Month

07

Day

Last follow-up date

2026

Year

09

Month

26

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2024

Year

09

Month

26

Day

Last modified on

2025

Year

10

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063571

Single case data URL

Value
https://center6.umin.ac.jp/ice/63571