The Effect of Education and Counseling on Reducing Pain and Anxiety in Women Undergoing Hysterosalpingography

Sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi (Other)

Overall Status

Completed

CT.gov ID

NCT03839147

Collaborator

(none)

105

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

This study investigates the effect of education and counseling on anxiety and pain in women undergoing hysterosalpingography as part of the infertility process.

Condition or Disease	Intervention/Treatment	Phase
Women's Health	Behavioral: Education and counseling	N/A

Detailed Description

Fertility and having a child is a significant experience for most individuals; however, many struggle to achieve pregnancy. Infertility is defined as the inability of a couple to conceive after 12 months of regular unprotected sexual intercourse or to carry a pregnancy to term. It is estimated that 10-15 % of the couples globally experience infertility. In Turkey, it is estimated that 10-20% of the couples are diagnosed with infertility. In the evaluation of infertile couples, hysterosalpingography (HSG) is a simple, safe, and minimally invasive radiologic procedure to visualize uterine cavity and tubes after contrast enhancement. HSG plays an important diagnostic role in finding the cause of infertility and in deciding the line of management. The aim of this study was to investigate the effect of education and counseling on anxiety and pain before the treatment of women who will have HSG procedure with the diagnosis of infertility.

This randomized controlled study was conducted at Gulhane Training and Research Hospital, Obstetrics and Gynecology clinic between May 2016 and January 2017. Volunteer women undergoing HSG as part of infertility evaluation have been included. Participants were randomly assigned to the intervention or the control group using a computer-generated list. A data collection form including socio-demographic and obstetric characteristics such as age, educational status, duration of infertility, previous pregnancies, births, abortion/curettage numbers, Spielberger State Anxiety Scale and Visual Analog Scale scores was used for each patient. After obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and VAS scoring scale were applied to both groups by face to face interview during the day giving appointment for HSG. Immediately after the questionnaires were applied, the nurse gave individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention (education and counseling) was performed.The IBM SPSS (Statistical package for the Social Sciences) 22.0 package program was used to evaluate the data obtained in the study.

Study Design

Study Type:

Interventional

Actual Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This randomized controlled study was conducted at Gulhane Training and Research Hospital, Obstetrics and Gynecology clinic between May 2016 and January 2017. The CONSORT (Consolidated Standards of Reporting Trials) guidelines for reporting randomised controlled trials (RCTs) has been used to describe the methods.This randomized controlled study was conducted at Gulhane Training and Research Hospital, Obstetrics and Gynecology clinic between May 2016 and January 2017. The CONSORT (Consolidated Standards of Reporting Trials) guidelines for reporting randomised controlled trials (RCTs) has been used to describe the methods.

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

The Effect of Education and Counseling on Reducing Pain and Anxiety in Women Undergoing Hysterosalpingography

Actual Study Start Date :

May 1, 2016

Actual Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Education and Counseling After obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and visual analogue scale scoring scale were applied to both groups by face to face interview during the day giving appointment for hysterosalpingography. Immediately after the questionnaires were applied, the nurse gave individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. This education consisted of the definition and the purpose of hysterosalpingography, when and how it was applied, in what cases it was applied, whether it was a painful procedure, possible side effects and additional benefits of infertility treatment	Behavioral: Education and counseling After obtaining informed consent, the data collection form, Spielberger State Anxiety Scale and VAS scoring scale were applied to both groups by face to face interview during the day giving appointment for HSG. Immediately after the questionnaires were answered, individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. In addition, the education and counseling given to the participants by the researcher was repeated briefly on the morning of the HSG procedure and any questions of the patients were answered.
No Intervention: Control group Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention (education and counseling) was performed. Both groups were re-evaluated using the same scales after the hysterosalpingography. Within 5 minutes of completing the hysterosalpingography procedure, participants were asked to evaluate their pain in order to characterize pain intensity using the visual analogue scale .

Arm

Intervention/Treatment

Experimental: Education and Counseling

After obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and visual analogue scale scoring scale were applied to both groups by face to face interview during the day giving appointment for hysterosalpingography. Immediately after the questionnaires were applied, the nurse gave individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. This education consisted of the definition and the purpose of hysterosalpingography, when and how it was applied, in what cases it was applied, whether it was a painful procedure, possible side effects and additional benefits of infertility treatment

Behavioral: Education and counseling

After obtaining informed consent, the data collection form, Spielberger State Anxiety Scale and VAS scoring scale were applied to both groups by face to face interview during the day giving appointment for HSG. Immediately after the questionnaires were answered, individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. In addition, the education and counseling given to the participants by the researcher was repeated briefly on the morning of the HSG procedure and any questions of the patients were answered.

No Intervention: Control group

Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention (education and counseling) was performed. Both groups were re-evaluated using the same scales after the hysterosalpingography. Within 5 minutes of completing the hysterosalpingography procedure, participants were asked to evaluate their pain in order to characterize pain intensity using the visual analogue scale .

Outcome Measures

Primary Outcome Measures

Spielberger State Anxiety Scale [30 minutes]
After completing the HSG procedure, participants filled out the Spielberger State Anxiety Scale. The Spielberger state anxiety scale was developed in 1964 by Spielberger. There are 20 statements in the scale that individuals can use to express their feelings. The State Scale measures the level of anxiety related to the situation and has been scored by four options for each expression. These are: "None" (1), "Slightly" (2), "Many" (3), "Completely" (4). The statements in this section are divided directly and reversed. Reversed statements are 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. The total score of the expressions which are reversed from the total score of the direct expressions and adding the number 50 which is the constant value of the state anxiety scale. Spielberger and his colleagues stated that 0-19 points obtained from the scale meant "no anxiety", 20-39 points meant "light", 40-59 points meant "medium", 60-79 points meant "heavy anxiety".
Visual Analog Scale for pain intensity [10 minutes]
After completing the HSG procedure, participants were asked to evaluate their pain in order to characterize pain intensity using the Visual Analog Scale (VAS). Patients indicated the maximum pain intensity experienced during the HSG by making a vertical line on the VAS. A standard ten-point visual analogue scale (VAS) of 0 to 10 was designed and used to assess the patients' perceptions of discomfort during the procedure. A high score on the scale indicated a high level of discomfort and a score of 0 denoted no discomfort at all. Patients indicate the degree of pain they feel between 0-10.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

being diagnosed with infertility
negative the result of the B-HCG testing
being able to understand, read and write in Turkish

Exclusion Criteria:

not wanting to be included in the study
not accepting education/counseling
not knowing Turkish
having additional diseases related to pelvic pain

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Investigators

Principal Investigator: Gulten Guvenc, University of Health Sciences, Gulhane Faculty of Nursing

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

ClinicalTrials.gov Identifier:

NCT03839147

Other Study ID Numbers:

50687469

First Posted:

Feb 15, 2019

Last Update Posted:

Mar 18, 2020

Last Verified:

Feb 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

hysterosalpingography

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Mar 18, 2020