NCT05790954

Brief Summary

The aim of this study is to evaluate the effect of guided imagery applied before cesarean section on preoperative anxiety, fear and physiological parameters. The study will be carried out in two different groups. The practice will start with meeting the women 3 days before cesarean section. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out random. The following applications will be made to the groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

March 27, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

March 17, 2023

Last Update Submit

February 21, 2024

Conditions

Cesarean Section

Outcome Measures

Primary Outcomes (2)

  • Change in anxiety

    The State-Trait Anxiety Inventory-S consist of 20 items with four points likert scales, each (not at all, somewhat, moderately so, very much so). Scores thus range between 20, indicating a low level of anxiety and 80, indicating a high level.

    Three days before the cesarean section, Fifteen minutes after preparation for cesarean section

  • Change in Surgical Fear

    Surgical Fear Questionnaire has been developed to determine the level of fear of patients who will undergo electrical surgery for the short and long -term results of surgical operation. The scale is a scales of 11 Likertes, which consist of 8 items, scored between 0-10. Each item 0 is scored as "I'm at all scared", 10 "I'm very scared". The total score of the scale is 0-80. The high score states that surgical fear is high.

    Three days before the cesarean section, Fifteen minutes after preparation for cesarean section

Secondary Outcomes (5)

  • systolic and diastolic blood pressure

    Fifteen minutes after preparation for cesarean section

  • heart rate

    Fifteen minutes after preparation for cesarean section

  • body temperature

    Fifteen minutes after preparation for cesarean section

  • respiratory rate

    Fifteen minutes after preparation for cesarean section

  • fetal heart rate

    Fifteen minutes after preparation for cesarean section

Study Arms (2)

Guided imagery Group

EXPERIMENTAL
Other: Guided imagery

Control Group

NO INTERVENTION

Interventions

Guided imageryOTHER

Three days before the cesarean section, the participants will be given a guided imagery audio recording and will be asked to listen to it before going to bed every evening until the day of the cesarean section. On the morning of the cesarean section, after the patient is prepared, the guided imagery audio recording will be played again.

Guided imagery Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • planned cesarean section
  • Single birth
  • giving birth at term
  • No hearing problems
  • Agreeing to participate in the research and obtaining written permission,

You may not qualify if:

  • Emergency cesarean section due to a health problem of the mother or baby
  • Not completing the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neslihan Yılmaz Sezer

Ankara, Mamak, 06620, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Imagery, Psychotherapy

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

March 17, 2023

First Posted

March 30, 2023

Study Start

March 27, 2023

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

February 22, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)